The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(6) Spinal tumor, and/or

(7) Failed previous fusion (pseudoarthrosis).

The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(7) Spinal tumor, and/or

(8) Failed previous fusion (pseudoarthrosis).

Device Description

The new GII-Ti-Poly-Axial Screw is intended to be used with the existing components, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. The previously cleared indications for use of the GII Spinal Fixation System are unchanged.

AI/ML Overview

Acceptance Criteria and Device Performance Study for GII-Ti-Poly-Axial Screw

This document describes the acceptance criteria and the study that proves the GII-Ti-Poly-Axial Screw meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Standard	Reported Device Performance
Mechanical Performance (Equivalence)	Equivalent to existing screw components of the cleared GII Spinal Fixation System (K980852, K032604, K051089)	"Test results demonstrate that the new GII-Ti-Poly-Axial Screw performs in a manner equivalent to the existing screw components of the cleared GII Spinal Fixation System."
Design Equivalence	Comparable design to predicate devices	"Equivalence can be seen in the comparable design..."
Material Composition Equivalence	Comparable material composition to predicate devices	"...material composition..."
Surgical Technique Equivalence	Comparable surgical technique to predicate devices	"...surgical technique..."
Intended Use Equivalence	Comparable intended use to predicate devices	"...intended use..."
Testing Characteristics Equivalence	Comparable testing characteristics to predicate devices	"...and testing characteristics of the GII system and other currently marketed spinal systems."

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Samples were tested according to accepted engineering and scientific principals." However, it does not provide specific details on:

The exact sample size used for the mechanical testing of the GII-Ti-Poly-Axial Screw.
The data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a mechanical device test, it is highly likely that the testing was performed in a laboratory setting, likely in Switzerland or at a contract testing facility, and therefore prospective in nature.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

For a mechanical device like a spinal screw, "ground truth" in the context of clinical outcomes or expert consensus on images is not directly applicable. The "ground truth" here is established by engineering standards and validated testing methodologies to confirm mechanical equivalence. The document does not specify the number or qualifications of experts involved in defining these engineering standards or conducting the tests. It broadly states, "Testing is complete. Samples were tested according to accepted engineering and scientific principals."

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., image reading). Since this study involves mechanical testing of a device's performance against established engineering standards, an adjudication method is not applicable in the traditional sense. The equivalence is demonstrated through objective mechanical measurements and data analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed to assess the impact of a device or AI on human reader performance, typically in diagnostic imaging. This type of study was not performed for the GII-Ti-Poly-Axial Screw, as it is a mechanical implant and not an imaging or diagnostic AI device. Therefore, there is no effect size for human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study (algorithm only) is relevant for AI/software devices. Since the GII-Ti-Poly-Axial Screw is a physical medical implant, a standalone performance study is not applicable in this context. Its "performance" is demonstrated through physical and mechanical testing, not algorithmic output.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering standards and validated mechanical testing protocols. The performance of the new GII-Ti-Poly-Axial Screw is compared directly against the performance characteristics of previously cleared predicate devices (K980852, K032604, K051089) within the GII Spinal Fixation System. This includes characteristics like design, material composition, and mechanical properties determined through testing.

8. Sample Size for the Training Set

For a mechanical device undergoing performance testing for substantial equivalence, a "training set" as understood in machine learning is not applicable. The device is not learning from data; its physical properties are being tested. If "training set" were to broadly refer to the predicate devices and their established performance data that serve as a benchmark, the document references several existing screw components from the GII Spinal Fixation System (K980852, K032604, K051089). The specific number of individual units of these predicate devices used to establish their performance is not provided in this summary.

9. How Ground Truth for the Training Set Was Established

Again, a "training set" in the AI sense does not apply here. However, if we interpret "ground truth for the training set" as the established performance baseline of the predicate devices, this baseline was established through:

Prior mechanical testing of the predicate devices according to accepted engineering and scientific principles.
Regulatory clearance (e.g., via previous 510(k) submissions K980852, K032604, and K051089) which confirmed their safety and effectiveness based on their design, materials, and performance data at the time of their clearance.
Adherence to recognized standards relevant to spinal implants (though specific standards are not cited in this summary).

Summary

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Section 5: 510(k) Summary

510(k) Summary of Safety Information	COLIGNE AG.
Premarket Notification, Section 510(k)	JULY 23, 2009

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

1. Device Name:
  Trade Name: GII-Ti-Poly-Axial Screw Common Pedicle screw spinal system Name(s):

Classification Pedicle screw spinal system Name(s):

Establishment Name & Registration Number: 2. Name: coLigne AG. 9614472 Number:

3. Classification(s):

Sec. § 888.3070 Pedicle screw spinal system

Device Class:	Class II for all requested indications
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
Product Code(s):	MNI, MNH, KWP

4. Equivalent Predicate Device:

COLIGNE AG. believes that the GII Spinal Fixation System modified by the inclusion of the GII-Ti-Poly-Axial Screw is substantially equivalent to the screws currently offered in the GII Spinal Fixation System identified below:

K980852 - K032604 and K051089 - GII Spinal Fixation System

Equivalence can be seen in the comparable design, material composition, surgical technique, intended use and testing characteristics of the GII system and other currently marketed spinal systems.

5. Device Description:

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Testing Summary. Testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new GII-Ti-Poly-Axial Screw performs in a manner equivalent to the existing screw components of the cleared GII Spinal Fixation System.

Indications For Use

(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(6) Spinal tumor, and/or

(7) Failed previous fusion (pseudoarthrosis).

(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(7) Spinal tumor, and/or

(8) Failed previous fusion (pseudoarthrosis).

Applicant Name & Address: 6.

coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 - fax Registration Number: 9614472

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver-Spring, MD 20993-0002

SEP 1 4 2009

Co-Ligne AG % Buckman Company, Inc. Mr. David W. Schlerf 2800 Pleasant Hill Road Suite 175 Pleasant Hill California 94523

Re: K083567

Trade/Device Name: GH Spinal Fixation System - Ti-Poly-Axial Screw Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: July 25, 2009 Received: September 10, 2009

Dear Mr. Schlerf:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. David W. Schlerf

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jarbare Buehr

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health ·

Enclosure

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Page _ 1 of of l

510(k) Number : K083567

Device Name(s): GII Spinal Fixation System - Ti-Poly-Axial Screw

(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (LS-S1) joint with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(6) Spinal tumor, and/or

(7) Failed previous fusion (pseudoarthrosis).

(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis.

(5) Kyphosis.

(7) Spinal tumor, and/or

(8) Failed previous fusion (pseudoarthrosis).

Prescription Use X OR Over-The-Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Kareem S. Burney for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Levices

(Optional format 1-2-96)

510(k) Number K083567

(Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.