TRABECULAR METAL VERTEBRAL BODY REPLACEMENT

K051978 · Implex Corp. · MQP · Sep 23, 2005 · Orthopedic

Device Facts

• Record ID: K051978
• Device Name: TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
• Applicant: Implex Corp.
• Product Code: MQP · Orthopedic
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer TMT Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

Device Story

Trabecular Metal Vertebral Body Replacement (VBR) system replaces diseased or damaged vertebral bodies and adjacent discs in the thoracolumbar spine (T1-L5). Device consists of porous tantalum; features rippled superior/inferior surfaces for stability; available in various heights/cross-sections. Used in anterior spinal surgery; requires supplemental internal spinal fixation. Surgeon selects appropriate size to tension spine; device provides structural support to collapsed/unstable vertebrae. Benefits include restoration of spinal column integrity following tumor or trauma.

Clinical Evidence

Bench testing only. Performance data included static and dynamic compression, static and dynamic torsion, and abrasion testing. Biocompatibility data provided to support material safety. No clinical data presented.

Technological Characteristics

Material: Porous Tantalum. Form factor: Vertebral body replacement implants with rippled superior/inferior surfaces. Mechanical properties validated via static/dynamic compression and torsion testing. Sterilization: Not specified.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) resulting from tumor or trauma (fracture). Intended for use with supplemental internal spinal fixation and optional bone graft.

Regulatory Classification

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.

Predicate Devices

• K010378
• K021025
• K021967
• K022563
• K031823
• K032527
• K051196

Reference Devices

• Signus medical implants (K022793, K041888, K043316)

Submission Summary (Full Text)

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K051978

SEP 2 3 2005

## 510(k) SUMMARY Trabecular Metal Vertebral Body Replacement System

| Submitter Name<br>And Address: | Zimmer Trabecular Metal Technology, Inc.<br>80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
|------------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Marci Halevi |
| Phone Number: | [phone] ext. 507 |
| Fax Number: | [phone] |
| Date Prepared: | July 11, 2005 |
| Device Trade Name: | Trabecular Metal Vertebral Body Replacement System |
| Device Common Name: | Vertebral Body Replacement Device |
| Classification Number<br>and Name: | 21 CFR § 888.3060<br>Spinal Intervertebral Body Fixation Orthrosis |

Device The Trabecular Metal Vertebral Body Replacement System is Description: designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.

> The Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.

> The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability.

- Indications for Use: The Zimmer TMT Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
- Device Technological The device is unique in comparison to predicates for this Characteristics and indication with regard to its geometry. The material has been Comparison to used in cited predicates for other applications. The Zimmer TMT Predicate Device: Vertebral Body Replacement System is substantially equivalent previously cleared components of this same system to (K010378, K021025, K021967, K022563, K031823, K032527 and K051196). The size range is comparable to the Signus

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KU51978 Trabecular Metal Vertebral Body Replacement Daye 2 of 2 Zimmer TMT ....... Special 510(k) Premarket Notification Medical implants described in K022793, K041888 and K043316. Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378). Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicate devices. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding: Static compression, . Dynamic compression, . . Static torsion, Dynamic torsion, and . . Abrasion.

Conclusion:

TMT Trabecular Metal The Zimmer Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology, Inc. 80 Commerce Drive Allendale, New Jersey 07401-1600

Rc: K051978

. K051776
Trade/Device Name: Zimmer Trabecular Metal Vertebral Body Replacement System Regulation Name: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 20, 2005 Received: July 21, 2005

SEP 2 3 2005

Dear Ms. Halevi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regars) to regally the Medical Device American procession in the commerce pror to Hay 20, 2017 - 3 de nees that have boom require approval of a premarket approval application (PMA). and Costiene Ace (110) that be nevice, subject to the general controls provisions of the Act. The r our may, mereroro, manus of the Act include requirements for annual registration, listing of general controls proficions 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 it may of sucject to cash of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA ean of tound in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actives made a determination that your device complies with other requirements of the Act that I Dri has made a actual regulations administered by other Federal agencies. You must or any I cacal statutes and regendents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF It 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 – Ms. Marci Halevi

This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you to organ manisang of substantial equivalence of your device to a legally prematics notification. "The sesults 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 rryou desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miornational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

2

- Mark N. Melkerson Acting 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): _K05-1978

Device Name: The Zimmer TMT Trabecular Metal Vertebral Body Replacement System

Indications for Use:

The Trabecular Metal Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 -- L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma ropidoo a conalization Metal Vertebral Body Replacement is intended from tradition of the rital internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

The Zimmer TMT Trabecular Metal Vertebral Body Replacement System

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K051978

(Posted November 13, 2003)

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