The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GII Spinal Fixation System.

Device Description

The implants consist of a system of flattened, cuboid, trapezoida & rectangular shaped implants. The OstaPek® VBR System implants offer substantial variation of size and configuration to better approximate the anatomical variation observed in different vertebral levels and patient anatomy. The devices are manufactured with one or more hollowed out central areas to accommodate bone graft material. The superior and inferior surfaces are manufactured in such a way that a series of lands and grooves are formed in the anterior/posterior direction. The purpose of these lands and grooves is to improve stability and bony fixation once the device is inserted. This device is made from the exact same material as the GII Spinal Fixation System, K051089.

AI/ML Overview

The OstaPek® VBR System is a vertebral body (partial or total) replacement device for the thoracolumbar spine (T1 - L5). It is intended to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation (specifically, the coLigne, AG, GII Spinal Fixation System).

This device falls under the classification § 888.3060, Spinal intervertebral body fixation orthosis, Class II, with product code MQP.

Here's an analysis of the provided information regarding the device's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance results in a table format. Instead, it makes a general statement about testing and equivalence to predicate devices.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance (Summary)
(Not explicitly defined with metrics)	Fatigue, static, and biocompatibility testing completed. Test results demonstrate that the new implants may be expected to perform in a manner equivalent or superior to the referenced comparison systems.

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

The document does not specify a sample size for any test set or provide information on data provenance (e.g., country of origin, retrospective or prospective). The "Testing Summary" only generally mentions "fatigue, static and biocompatibility testing." These types of tests typically involve material samples and mechanical setups rather than clinical patient data.

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

This information is not provided in the document. Given that the testing mentioned is primarily mechanical (fatigue, static) and biocompatibility, it's unlikely that clinical expert ground truth was established in the traditional sense for these specific tests.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the described testing (mechanical and biocompatibility).

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

A MRMC comparative effectiveness study was not conducted or reported in this document. The device is a physical implant, not an AI-assisted diagnostic or decision-support tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an algorithm or AI was not conducted or reported. The device is a physical implant.

7. Type of Ground Truth Used

The ground truth for the "Testing Summary" would likely be based on engineering standards and specifications for fatigue, static load, and biocompatibility, rather than expert consensus, pathology, or outcomes data. The document states "tested according to accepted engineering and scientific principals." This implies that the performance was compared against established benchmarks or the performance of predicate devices under similar test conditions.

8. Sample Size for the Training Set

An AI training set and its sample size are not applicable as this device is a physical implant and not an AI/algorithm-based product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no AI training set for this device.

Summary of Device Performance Justification:

The coLigne AG. justifies the OstaPek® VBR System's performance and safety by demonstrating its substantial equivalence to existing predicate devices (Lanx VBR, Concord VBR, Theken LPOD, VBR). This equivalence is asserted in terms of design, material composition, surgical technique, and intended use. The document explicitly states that "fatigue, static and biocompatibility testing is completed... Test results demonstrate that the new implants may be expected to perform in a manner equivalent or superior to the referenced comparison systems." This suggests that the device underwent standard mechanical and biological safety testing, and its performance met or exceeded that of its predicates, though the specific quantitative results are not detailed.

Summary

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K07232

JUN 2 4 2008

510(k) Summary InformationPremarket Notification, Section 510(k)		COLIGNE AG.MAY 7, 2008
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1.	Device Name:
	Trade Name: OstaPek® VBR System
	CommonName(s): Vertebral body replacement
	ClassificationName(s): Spinal vertebral body replacement device
2.	Establishment Name & Registration Number:
	Name: coLigne AG.Number: 9614472
3.	Classification(s):
	Sec. § 888.3060
	Device Class: Class IIClassification Panel: Orthopaedic and Rehabilitation Devices PanelProduct Code(s): MQP
4.	Equivalent Predicate Device:

coLigne AG. believes that the OstaPek® VBR is substantially equivalent to the VBR systems identified below:

K052384 - Lanx VBR, Lanx, LLC K052746 - Concord VBR, DePuy Spine, Inc. K032064 - Theken LPOD, VBR, Theken, Surgical

Equivalence can be seen in the design, material composition, surgical technique and intended use.

5. Device Description:

Testing Summary. Fatigue, static and biocompatibility testing is comples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new implants may be expected to perform in a manner equivalent or superior to the referenced comparison systems.

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K072326 (pg. 2 of 2)

Indications for Use.

6. Applicant Name & Address:

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

7. Company Contact:

Robert Lange coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 – fax

Submission Correspondent: 8.

Mr. David W. Schlerf Buckman Company, Inc. 1070 Concord Avenue, Suite 230 Concord, CA 94520-5646 925.768.0247 - 925.356.2654 -- fax schlerf@comcast.net or david@fda-help.com

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

coLigne AG % Buckman Company, Inc. Mr. David Schlerf 1070 Conrad Avenue, Suite 230 Concord, CA 94520

Re: K072326

Trade/Device Name: OstaPek® VBR System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 14, 2008 Received: June 18, 2008

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.

JUN 2 4 2008

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 - Mr. David Schlerf

This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1

14072326 510(k) Number :

Device Name(s): OstaPek® VBR System

Indications For Use:

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)

Deubare Muehm
Division St. Oto

Division of General, Restorative, and Neurological Devices

(Per 21 CFR 801.109)

510(k) Number_K07324

(Optional format 1-2-96)

OstapekVBR.doc

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.