The Creaspine SupStance Vertebral Body Replacement System, Line Extension, (SupStance VBR System) is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

Device Description

The proposed Creaspine SupStance VBR System, Line Extension, is a modification of the original Creaspine SupStance VBR System that was the subject of K072537. This device modification has been submitted as a Special 510(k) Premarket Notification because the proposed SupStance VBR System, Line Extension, is identical in intended use and fundamental scientific technology to the parent SupStance VBR System originally described in K072537.

The modifications made to the parent device to produce the proposed SupStance VBR System, Line Extension, are limited to the expansion of the implant (cage) dimensions available.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: the Creaspine SupStance Vertebral Body Replacement System, Line Extension. This document primarily focuses on establishing substantial equivalence to previously cleared devices through mechanical testing and does not describe a clinical study involving human patients or a software algorithm evaluated with clinical data.

Therefore, many of the requested items regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted based on the provided text, and where certain requested information is N/A:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Mechanical properties comparable to predicate devices in:	Data confirms mechanical properties are comparable to predicate devices in:
- Static compression testing	- Static compression testing
- Dynamic compression testing	- Dynamic compression testing
- Static torsion testing	- Static torsion testing
- Dynamic torsion testing	- Dynamic torsion testing
- Expulsion testing	- Expulsion testing
(Note: Specific quantitative targets or ranges for acceptance criteria are not provided in this summary, only the qualitative statement of "comparable" to predicates)	(Specific quantitative results are not provided in this summary, only the qualitative statement of "comparable" to predicates)

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

Sample size for test set: Not applicable for a software algorithm evaluated with clinical data. This submission is for mechanical testing of a physical implant. The document does not specify the number of physical devices or tests performed, only that "Performance testing included the types of mechanical testing recommended..."
Data provenance: Not applicable. The data is generated from mechanical testing in a lab setting, not from a clinical patient population.

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

Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. This submission involves mechanical testing of a physical implant, not a clinical study requiring adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not relevant for this type of device (a physical spinal implant) or the type of data presented (mechanical testing). This study does not involve human readers interpreting clinical cases with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical spinal implant, not a software algorithm.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established for vertebral body replacement systems, likely based on relevant standards and predicate device performance. The study aims to demonstrate that the new device's mechanical properties meet these established engineering benchmarks and are comparable to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is mechanical testing of a physical medical device, not a machine learning model. There is no "training set" in this context.

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

Not applicable. See point 8.

Summary

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K081564 (pg. 1 of 2)

JUN 3 0 2008

SPECIAL 510(K) SUMMARY

Creaspine SupStance Vertebral Body Replacement System, Line Extension

Proprietary Name:	Creaspine SupStance Vertebral Body Replacement System
Common Name:	Spinal Vertebral Body Replacement System
Proposed Regulatory Class:	Class IISpinal intervertebral body fixation orthosis21 CFR 888.3060
Device Product Code:	87 MQP, Spinal Vertebral Body Replacement Device
For Information Contact:	Marc BernardRegulatory Affairs Director
	PTIB Xavier ArnozanAvenue du Haut-Lévèque33600 Pessac - FranceTelephone +33 557 102 854Fax: +33 557 102 886Email: marc.bernard@creaspine.com
Date Summary Prepared:	June 3, 2008

Predicate Devices

The proposed Creaspine SupStance Vertebral Body Replacement System (SupStance VBR System), Line Extension is substantially equivalent to the Creaspine SupStance VBR System subject of K072537 and the following legally marketed spinal vertebral body replacement devices:

Surgical Titanium MeshIM System (DePuy-Acromed™, Inc., K003043) .
Surgical Dynamics Mesh Cage System (United States Surgical, K003709) �

Device Description

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The modifications made to the parent device to produce the proposed SupStance VBR System, Line Extension, are limited to the expansion of the implant (cage) dimensions available. The line extension includes the implants with the length and diameter combinations bolded in the following table:

Diameter	Ø19	Ø22	Ø25	Ø28
Angulation	0°	5°	5°	5°
Length	30	30	30	30
	32.5	32.5	32.5	32.5
	35	35	35	35
	37.5	37.5	37.5	37.5
	40	40	40	40
	42.5	42.5	42.5	42.5
	45	45	45	45
	47.5	47.5	47.5	47.5
	50	50	50	50
			52.5	52.5
			55	55

Intended Use

The SupStance VBR System, Line Extension is a vertebral body replacement system intended to replace a vertebral body. The SupStance VBR System is designed for use in the thoraco-lumbar spine (T1- L5) to replace a collapsed, damaged, or unstable vertebral body during tumor or trauma (i.e., fracture) management procedures. The SupStance VBR System is intended to be used with supplemental internal fixation systems. Anterior thoracolumbar plates and screws or pedicle screw and rod systems are among the options for the surgeon to use.

The use of allograft and/or autograft with the SupStance VBR System is optional.

Statement of Technological Comparison

The subject device shares the same intended use, basic design concepts, and materials as that of the predicate devices. Performance testing included the types of mechanical testing recommended for vertebral body replacement systems (static and dynamic compression testing, static and dynamic torsion testing, and expulsion testing) in the "FDA Guidance for Industry and FDA Staff, Spinal System 510(k)s" (issued May 3, 2004). The data collected confirms that the mechanical properties of the proposed line extension to the SupStance VBR System product line are comparable to those of the predicate devices. The information and data collected support a claim of substantial equivalence for the proposed SupStance VBR System, Line Extension to the specified predicate devices.

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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 caduceus symbol on the right, which is a staff entwined with snakes, representing medicine and health. To the left of the caduceus is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PTIB Xavier Arnozan % Mr. Marc Bernard Regulatory Affairs Director Avenue du Haut-Lévèque 33600 Pessac-France

JUN 3 0 2008

Re: K081564

Trade/Device Name: Creaspine SupStance Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 3, 2008 Received: June 4, 2008

Dear Mr. Bernard:

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 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. Marc Bernard

This letter will allow you to begin marketing your device as described in your Section 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 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. Mullean

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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INDICATIONS FOR USE

510(k) Number (if known): K081564

Device Name: Creaspine SupStance Vertebral Body Replacement System, Line Extension

Indications for Use:

The use of allograft and/or autograft with the SupStance VBR System is optional.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological, Restorative, and Neurological Deveral,

June 3, 2008

age 1 of 1

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.