Alphatec Spine

Confidential

OsseoScrew Instruments
Table of Contents
1.0
1.1
1.2
1.3
1.4
1.5
1.6
2.0
2.1
2.2
3.0
4.0
5.0
6.0
6.1
6.2
7.0
7.1
7.2
8.0
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.8
9.0

Device Description...................................................................................................3
Product Summary.................................................................................................3
General Information .............................................................................................4
Product Specification ...........................................................................................7
Reference to similar and previous generations of the device ..............................7
Storage Method and Expiration Date ...................................................................7
Comparison with Similar Medical Devices (Predicates) .....................................7
Labeling ...................................................................................................................7
Instructions for Use and Basis for Establishing Its Contents...............................7
Label Sample .......................................................................................................8
Device Design Process .............................................................................................8
Manufacturing ..........................................................................................................9
Design and Manufacturing Site .............................................................................10
Essential Principles and Evidence of Conformity .................................................10
Essential Principles ............................................................................................10
List of Reference Standards ...............................................................................10
Risk Analysis and Control Summary.....................................................................11
Risk Analysis System ........................................................................................11
Risk Management Report ..................................................................................11
Product Validation and Verification ......................................................................12
Physical and Chemical Properties ......................................................................12
Biocompatibility ................................................................................................12
Cleaning Methods ..............................................................................................13
Sterilization Method...........................................................................................13
Safety and Durability (Shipping Study) .............................................................14
Medical Device Design Verification .................................................................14
Clinical Evaluation.............................................................................................15
Studies to Support Usage Method (Simulated Use Validation).........................15
Declaration of Conformity .....................................................................................15

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List of Tables
Table 1.
Table 2.
Table 3.
Table 4.
Table 5.
Table 6.

OsseoScrew Instrument Part Numbers and Descriptions .............................. 3

Overview of Materials and Coatings ........................................................... 13
Validated Sterilization Parameters .............................................................. 14
Shipping Validation Reports by Set Number .............................................. 14
Design Verification Reports ........................................................................ 14
Design Validation / Simulated Use Reports ................................................ 15

List of Figures
Figure 1.
Figure 2.
Figure 3.
Figure 4.
Figure 5.
Figure 6.

OsseoScrew Shown Undeployed and Deployed .......................................... 5

Features of the Instrument for Implantation and Deployment ..................... 6
Sample Label for Individual Instrument ...................................................... 8
Design Process Diagram .............................................................................. 9
Risk Management Process (ISO 14971) .................................................... 11
Risk Classification Matrix.......................................................................... 12

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Device Description
1.1
Product Summary
The OsseoScrew MIS and OsseoScrew Spinal Fixation System facilitates the surgical
correction of spinal deformities and mechanical instability by providing temporary
internal fixation and stabilization during bone graft healing and/or fusion mass
development. The implants are manufactured from surgical grade titanium alloy (Ti-6Al4V ELI or Ti-6Al-4V) and commercially pure titanium (Ti grade 2). All implants are
intended for single use only and should not be reused. The OsseoScrew System implants
are pedicle screws with an expanding region on the screw shank that is intended to
improve bony fixation. The OsseoScrew Implants and Single Use Instruments (Class IIb
and Class IIa) are declared conforming in technical file TECH-001020.
The reusable instruments, the subject of this technical file, are listed below in Table 1.
Table 1. OsseoScrew Instrument Part Numbers and Descriptions
Part Number

Description

Deployment Shaft
(see TECH-001020)
Inserter Instrument Handle
54900

T-Handle
54900-02

Polyaxial High Top /MIS

Screw Drivers
54900-03, 54990-03
Trial Probes
54900-20-01, 54900-20-02
Retriever tool
54900-30
Un-deployment Tools
54900-40, 54990-40

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General Information

a) A general description including its intended purpose

When used in conjunction with the Zodiac Polyaxial Spinal Fixation System or the Illico
MIS Posterior Fixation System, the OsseoScrew Spinal Fixation System is intended to
aid in the surgical correction of various spinal deformities and pathologies of the spine. It
is intended to provide stabilization during the development of fusion utilizing a bone
graft. The OsseoScrew implant is intended for use in the patient population with
compromised bone.
It is intended that this device, in any system configuration, be removed after development
of solid fusion mass.
b) Intended patient population and medical condition to be diagnosed and/or
treated and other considerations such as patient selection criteria
The OsseoScrew MIS and OsseoScrew Spinal Fixation System are intended for posterior,
non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the
following indications: degenerative disc disease (defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e.,
scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The OsseoScrew implant is intended for use in patients with compromised bone.
c) Principles of operation
The instruments of the OsseoScrew System are to provide the necessary tools for
insertion and deployment of the OsseoScrew Implant. The implant is intended to provide
surgeons with the ability to place a larger screw in the vertebral body when the pedicle
size limits the size of the pedicle screw that can be placed. For example, if a smaller
pedicle would normally limit the surgeon to a maximum size 6.5mm solid shank
pedicle screw, the surgeon can now select the OsseoScrew 6.5mm screw and expand
the shank in the vertebral body up to a final diameter of 10.0mm.
d) Risk class and the applicable classification rule
The instruments of the OsseoScrew System are classified as Class I per MDD
93/42/EEC, Annex VII, Rule 6.
e) An explanation of all novel features
The OsseoScrew implant is a pedicle screw with an expandable section. This implant is
inserted into the vertebral body in a reduced configuration. It is initially placed using an
interfacing driver. After the screw is placed, it can be expanded radially to increase the
screw diameter distal to the pedicle as shown in Figure 1. Radial expansion and
expanded refers to the increased diameter of the implant when associated
instrumentation applies an axial force to compress the implant. The screw can also be
undeployed and removed.

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Figure 1. OsseoScrew Shown Undeployed and Deployed

f) A description of the accessories, other medical devices and other products that
are not medical devices, which are intended to be used in combination with it
A full spinal construct can be built with the OsseoScrew Spinal Fixation System using the
components from the previously cleared Zodiac Polyaxial Spinal Fixation System or
Illico Posterior Fixation System. The OsseoScrew Spinal Fixation system is an adjunct
system to be used with the Zodiac Polyaxial Spinal Fixation or Illico Posterior Fixation
System. The deployment shaft is considered an accessory to the system and is provided
as a single use device.
g) A description or a complete list of the various configuration/variants of the
device that will be made available
The OsseoScrew instruments are sold as part the OsseoScrew MIS and OsseoScrew
Spinal Fixation System. The instruments are available individually and as sets which are
described in Table 1. There are no other configurations/variants of this device.
h) A general description of the key functional elements, e.g. its parts/components
(including software if appropriate), its formulation, its composition, its
functionality. Where appropriate, this will include: labelled pictorial
representations (e.g. diagrams, photographs, and drawings), clearly indicating key
parts/components, including sufficient explanation to understand the drawings and
diagrams.
The OsseoScrew inserter/deployment instrument is a multi-component item as shown in
Figure 2. During the procedure, the implant is inserted into the pedicle and engaged by
turning the screw driver feature. Once in place, the Deployment Shaft is inserted into the
tip of the implant. The threads on the distal end of the deployment shaft deploy (expand)
the implant and allows the undeployment tool to undeploy the screw for removal.

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Figure 2. Features of the Instrument for Implantation and Deployment

i) A description of the materials incorporated into key functional elements and

those making either direct contact with a human body or indirect contact with the
body
The OsseoScrew Spinal Fixation System Instruments that come into contact with the
human body are transient use instruments defined as being intended for continuous use
for less than 60 minutes (continuous being defined as uninterrupted actual use for its
intended purpose) as per the MDD Directive 93/42/EEC.
All OsseoScrew System instruments are manufactured from biocompatible materials that
are well characterized and widely used for instruments in the orthopedic medical device
industry in the US and EU. A list of materials is provided in Table 2.

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Product Specification

This implant is a titanium polyaxial pedicle screw with an expansion section as illustrated
in Figure 1. The OsseoScrew implant can be used either deployed or not deployed at the
surgeons discretion using the instruments in the OsseoScrew Set.
Instruments were designed to be intuitive, easy to use, have acceptable ergonomics and
perform as intended in user validations. In addition, the instruments repeatedly,
reproducibility, and securely engage an OsseoScrew implant; Detect location of the peak
expansion zone of the screw; Disengage from the implanted OsseoScrew after
implantation with or without prior deployment; Deploy the OsseoScrew into the vertebral
body; Undeploy the OsseoScrew; Remove screw and screw tip if separate during screw
removal; And require no more than Iwo hands to use. All materials used in the
instrumentation are able to withstand repeated steam sterilizations and are biocompatible.
1.4

Reference to similar and previous generations of the device

The OsseoScrew System is currently CE marked. This STEDA is updating the Technical
File to current standards.
1.5

Storage Method and Expiration Date

Similar to other Alphatec instrument sets, the OsseoScrew Instruments are packaged in
tray inside of a steam sterilization case. The trays are etched with the outline of the parts
to assist in placing components into the trays. The trays have plastic inserts to hold the
components during transit. The instrument trays fit within the sterilization case which is
labeled with a kit identification label. The instrument sets are provided non-sterile;
therefore, there is no expiration date. The components in the set are also available
individually. Components are labeled with part number and lot number and provide in
sealed containers.
1.6

Comparison with Similar Medical Devices (Predicates)

The features of the OsseoScrew Expandable Pedicle Screw are similar to standard pedicle
screws such as the Zodiac and Illico Systems. The OsseoScrew implants are inserted into
the pedicle using the same technique and instruments used with standard pedicle screws
using either open procedure or MIS approach. Once the OsseoScrew is in place, unique
tools are used to deploy the expandable section similar to the EBI Omega21 Spinal
Fixation System.
2.0

Labeling

The OsseoScrew System labeling is in compliance with MDD Annex I Section 13, EN 1041 and
ISO 15223. All instruments are laser marked with the part number, lot number, Alphatec logo,
and the CE mark. The package labeling content is based on the requirements of MDD
93/42/EEC Annex 1 Section 13. Labeling includes packaging labels, instructions for use (IFU),
and surgical technique guides. Package labeling and IFU are translated into French, Italian,
German, Spanish, Greek, and Portuguese.
2.1

Instructions for Use and Basis for Establishing Its Contents

The Instructions For Use (IFU), contains the indications, contraindications, warnings and
precautions, preoperative management, perioperative management, and postoperative
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management. Validated process steps for cleaning and sterilization are also provided in
the IFU.
2.2

Label Sample

Surgical sets, such as the OsseoScrew Instrument Sets, are assigned set identification
labels per PRO-000020 and SOP-021 Surgical Set Configuration Creation and Revision
Procedure. The set IDs are not translated; however, a copy of the translated IFU is
provided in each kit. A sample label for an individual component is shown in Figure 3.
Figure 3. Sample Label for Individual Instrument

3.0

Device Design Process

The instruments were designed to interface with the implants and to meet the user needs. The
Design Control process at Alphatec Spine is controlled and documented per ENG-001 Design
Controls Procedure. This product development procedure assures that appropriate quality
objectives and requirements are established, and that risk analysis is performed during the
process to assure potential risks are addressed and mitigated. Each phase is designed with the
appropriate deliverables and assigned team member functional requirements. Executive reviews
are conducted at the end of each phase as a requirement to enter the next phase.
Phase I
Phase II
Phase III
Phase IV
Phase V
Phase VI

Market Needs Assessment and Business Case

Design Inputs
Design Outputs
Design Verification and Validation
Process Validation and Transfer
Product Release and Surveillance

The product development process at Alphatec Spine is structured to meet the requirements of
ISO 13485 and FDA Design Controls.

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Figure 4. Design Process Diagram

4.0

Manufacturing

The instrument sets consist of purchased components assembled in a sterilization container

purchased from qualified vendors according to drawings provided by Alphatec Spine. The
OsseoScrew System instruments are laser marked with their respective part number, lot number
and size by the outside vendors. Additionally, the Alphatec Spine logo and the CE mark are also
laser marked onto each instrument. The components are inspected by Quality Control (QC) per
the approved quality inspection report.
System instruments are provided non-sterile. The OsseoScrew instruments are packaged in
surgical trays or provided individually in the same manner as other spinal systems offered by
Alphatec Spine Inc. When provided as a system in an aluminum sterilization tray, instruments
are positioned within snapping plastic inserts to prevent movement during transit. The trays are
etched with outline of the part to assist in proper placement of devices in the tray.

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Design and Manufacturing Site

The products described in this summary technical document were designed and developed by
Alphatec Spine Inc. Alphatec Spine has ISO 13485 certified design and manufacturing facilities.
Alphatec Spine is registered with the FDA as well as an EU Authorized Representative and
Notified Body. Alphatec Spine facilities, licensing and registrations are listed below:
Facilities:
Design Facility

Manufacturing Site

Alphatec Spine, Inc.

5818 El Camino Real
Carlsbad, CA 92008, USA
Alphatec Spine, Inc.
5830 El Camino Real
Carlsbad, CA 92008, USA

Licenses and Registrations:

US FDA Device Establishment Registration
Owner/Operator ID
Registration Number
EU
Authorized
Representative

Notified Body

6.0

Alphatec Holdings
Alphatec Holdings

9072657
2027467

Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Intertek Semko AB
Box 1103, SE-164 22 Kista, Sweden

Essential Principles and Evidence of Conformity

6.1

Essential Principles

The applicable sections of the essential requirements have been identified and are
documented in the Essential Requirements Checklist. A rationale is provided for any
requirement(s) deemed not applicable. The Essential Requirements Checklist is located
in the Technical File.
6.2

List of Reference Standards

The OsseoScrew Spinal Fixation System conforms to all applicable referenced standards.
A list of applicable reference standards is located in the Technical File.

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Risk Analysis and Control Summary

7.1
Risk Analysis System
A risk analysis was conducted per PRO-000003 Risk Management which is in
compliance with ISO-14971. The goals of the risk management process are to:

Determine potential failure modes/hazards associated with product design, product

fabrication, product use, human factors and environmental factors.
Estimate the risk associated with each hazardous situation
Assess and implement risk control measures to mitigate risk to an acceptable level.
Evaluate residual risk and risk arising from risk control measures.
Figure 5. Risk Management Process (ISO 14971)

7.2

Risk Management Report

The evaluation of initial risks was identified by the following cross functional members
of the project team performing the risk assessment: Engineering, marketing, medical
education, regulatory affairs, quality, and manufacturing engineering. An evaluation of
potential risks was performed along with identification of preventive actions. These
actions were designed to ensure that potential risks were mitigated as much as possible
through the design process and that no new risks were identified.
Using the Risk Classification Matrix (Figure 6), green is acceptable, red is unacceptable,
and risks that are yellow are reduced as much as reasonably possible.

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Severity

Figure 6. Risk Classification Matrix

5. Catastrophic
4. Critical
3. Serious
2. Minor
1. Negligible

RMRP
RMRP
RMRP
RMRP
1. Improbable

RMRP
2. Remote 3. Occasional 4. Probable
Probability of Failure

RMRP
5. Frequent

After Initial Risk Classification, Preventive Actions were designed to reduce assessed
risk. The purpose of applying risk control measures was to mitigate risk to an acceptable
level. Actions and solutions were identified according to the following priority: Inherent
safety by design, protective measures in the medical device itself or in the manufacturing
process, and information on safety.
After completion of all mitigating activities, all risks were reduced to an acceptable level.
The team has determined that all risk control measures were implemented effectively to
reduce the overall risk of the OsseoScrew Spinal Fixation System Instruments to
acceptable, and the benefits of this system outweigh the risks.
8.0

Product Validation and Verification

The verifications and validations performed for the OsseoScrew Spinal Fixation System are
listed below. All acceptance criteria were met. The system does not: contain software,
medicinal substances, or a power source, have issues with electromagnetic compatibility, emit
radiation, have moving parts, or require animal studies.
8.1

Physical and Chemical Properties

The OsseoScrew System Instruments are manufactured from medical grade materials
(conforming to ASTM standards) widely used in surgical instruments. A Certificate of
Conformity (C of C) accompanies each shipment and provides test results as proof of
conformance for physical and chemical properties.

8.2

Biocompatibility

The OsseoScrew Spinal Fixation System Instruments are reusable surgically invasive
devices and as such, are classified as Class I devices as per the MDD Directive
93/42/EEC. The device is classified in accordance with ISO 10993-1 as:
Category: External Communicating Device
Contact: Tissue/Bone/Dentin
Contact Duration: A, Limited Exposure
The instruments are manufactured from medical grade materials that are commonly used
for surgical instruments: 455, 465, 17-4, 17-7 and 18-8 Stainless Steel, and RADEL are
acceptable biocompatible material for manufacturing of surgical instruments.
The metal instruments are passivated, electropolished, or chromium coated that is
common to these types of instruments. An overview of the raw materials and coatings
for the proposed instruments and the biocompatibility standards met are given in Table 2
below.
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All materials and finishes used in the OsseoScrew instruments have been historically
used in previously released Alphatec Products and within the medical industry and
therefore are deemed acceptable for use within the OsseoScrew System. The
biocompatibility assessment, BIO-100047, is available in the technical file.
Table 2. Overview of Materials and Coatings
Instruments

Instrument
Finish

Material
RADEL R-5000 PPSU
Stainless Steel, 18-8,
Stainless Steel 455, 465, 17-4
Titanium Ti-6Al-4V
Aluminum Alloy AL-6061
Chromium Coat

Specification
ASTM D6394
ASTM A276
ASTM A564 / A564M
ASTM F1472
ASTM B211. B210, B221
ASTM B177, ASTM A380,
ASTM B849, ASTM B850,
ASTM B254

ISO-10993 Classification
Category: External
communicating device
Contact: Tissue/bone/dentin
Contact duration: A
limited (24hrs)

8.3
Cleaning Methods
The instrument sets are provided non-sterile with instructions for cleaning prior to
sterilization. The instructions for use contain step by step procedures for manual and
automated machine cleaning. The acceptance criteria for the test items was to be visibly
clean with an unaided eye and achieve a 3-log 10 reduction in bioburden after cleaning.
Manual Cleaning
The cleaning method developed is a series of rinses, enzymatic, and detergent cleaning
followed by a reverse osmosis/deionized water rinse. The instruments can be dried using
filtered compressed air or a clean lint free cloth.
The manual cleaning method met protocol requirements. The prescribed method achieved
a 3-log 10 reduction in bioburden for G. stearothermophilus and E. Coli. The manual
cleaning method left all devices visibly clean with the unaided eye. Reference test report:
TR-545 OsseoScrew Cleaning Validation Report
Automated Cleaning
When using the automated cleaning method, the instructions for use requires a set of precleaning steps be performed prior to running the machine cycle. These steps include a
series of rinses, enzymatic and detergent cleaning followed by a reverse
osmosis/deionized water rinse before placing in the automatic cleaner in the open
position. The automated cleaning cycle parameters are to use an enzyme wash, a
detergent wash, and purified hot water rinse.
The automated cleaning method met protocol requirements. The prescribed method
achieved a 3-log 10 reduction in bioburden for G. stearothermophilus and E. Coli. The
pre-cleaning with the automated cleaning left all devices visibly clean with the unaided
eye.
8.4
Sterilization Method
Steam Sterilization Validations were conducted for the surgical instrument set. The test
sample, considered worst case, was represented by a fully populated set with regards to
material, mass and sterilant flow. The instruments were cleaned using the validated
cleaning method and placed in the sterilization case. The sterilization used the
parameters listed in Table 3.
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Table 3. Validated Sterilization Parameters

Set number

Sterilization
Method

Sterilization
Type

Temperature

Cycle
Time

Dry
Time

SKIF-52111-05
SKIF-52111-06

Steam

Pre-Vacuum

270 F 4F
(132 C 2C)

30

The results showed that the OsseoScrew System Sets were sterilized to a SAL of 10-6
using the BI overkill method using Geobacillus stearothermophilus as the indicator
organism. Dry time testing was successfully completed using full cycle parameters.
Both SAL and dry time testing were successfully completed and that the provided
sterilization parameters are validated to ensure that the acceptance criteria of a SAL 106
were met.
8.5
Safety and Durability (Shipping Study)
The shipping validations for the OsseoScrew System were tested in accordance with
ISTA-3A. Two shipping validations were performed to ensure that the OsseoScrew
System can withstand the stresses of the distribution and shipping environment. Both
shipping validations passed the acceptance criteria and are considered successful. The
report numbers are shown in Table 4.
Table 4. Shipping Validation Reports by Set Number
Set number
TR-517
TR-505

Test Report
OsseoScrew Ship Test Report
Shipping Report for Development Shaft

The results demonstrate that the OsseoScrew Instrument Sets can withstand the stresses
of the distribution and shipping environment and the shipping validations are considered
successful.
8.6
Medical Device Design Verification
Design verification testing performed, on the OsseoScrew System, is listed in Table 5.
Table 5. Design Verification Reports
Report
TR-196
TR-199
TR-281
TR-304
TR-310
TR-332
TR-333

Process
OsseoScrew Deployment Instrument Verification testing
Osseoscrew Instruments Design Validation and Feedback on Prototypes
Verification Strength of the Snap Ring Stop for the 21107 Actuator
Verification Friction of Actuator after Repeat Processing Through Autoclave Cycle
Verif. Wear Resistance & Friction of the Actuator after Cycle Testing Under Load
Verif. Friction of Actuator with Thrust Washer after Repeat Autoclave Cycle
Verification Wear Resistance & Friction of the Actuator w/ Thrust Washer After
Cycle Testing under Load
TR-388 OsseoScrew Deployment shaft life cycle testing
TR-389 Driver hex cannulation testing
TR-527 OsseoScrew Surgical Set Sterilization Validation
TR-545 OsseoScrew Instrument Cleaning Validation
TR-559 Undeployed Instrument Verification Testing
REC-000123 Design Validation of OsseoScrew MIS Driver and Trial Probes

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Clinical Evaluation

A clinical data compilation was completed of relevant scientific literature currently

available on the intended purpose of the device. A compilation of pertinent clinical data
from published literature for this product has been conducted in accordance with
Alphatec Spine procedure REG-009, Conducting a Clinical Data Compilation for CE
Marking.
The clinical condition and safety of patients, the safety and health of users, and any risks
when weighed against the benefits to the patient, are compatible with a high level of
patient and user health and protection. The clinical evaluation report, CE-016, is
provided in the Technical File.
8.8

Studies to Support Usage Method (Simulated Use Validation)

The goal of the simulated use validation process is to evaluate performance of the
instruments under various conditions per the design intent. Surgeons were asked to
implant the OsseoScrew, in a cadaver lab setting, using the instruments in the set. They
were required to complete a survey with their evaluation on performance of each
instrument. There were three successful studies performed and the results are
documented in the reports listed in Table 6.
Table 6. Design Validation / Simulated Use Reports
Report#
TR-199
TR-550
TR-708

9.0

Description
OsseoScrew Instruments Design Validation
OsseoScrew Instrument Design Validation
Design Validation of OsseoScrew MIS Driver and Trial Probes

Declaration of Conformity

Alphatec Spine, Inc. issued a declaration of conformity for the OsseoScrew Spinal Fixation
System Instruments when used in a manner consistent with the intended use. The EC
Declaration of Conformity and the applicable device part numbers can be found the Technical
File.

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