TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1

K051196 · Implex Corp. · MQP · Jun 17, 2005 · Orthopedic

Device Facts

• Record ID: K051196
• Device Name: TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
• Applicant: Implex Corp.
• Product Code: MQP · Orthopedic
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 (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

Vertebral body replacement (VBR) system for thoracolumbar spine (T1-L5); replaces collapsed, damaged, or unstable vertebral bodies due to tumor or trauma. Device consists of porous tantalum (Trabecular Metal); available in various cross-sections and heights to tension spine; superior/inferior surfaces feature ripple pattern for stability. Used in surgical setting via anterior approach; implanted by surgeons. Requires supplemental internal spinal fixation. Benefits include structural support for spinal column; restoration of vertebral height.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance testing included static and dynamic compression, static and dynamic torsion, and abrasion testing. Biocompatibility data provided to support material usage.

Technological Characteristics

Material: Porous Tantalum (Trabecular Metal). Design: Vertebral body replacement with ripple-patterned superior/inferior surfaces. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Software: None.

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

• Trabecular Metal Vertebral Body Replacement System (K010378)
• Trabecular Metal Vertebral Body Replacement System (K021025)
• Trabecular Metal Vertebral Body Replacement System (K021967)
• Trabecular Metal Vertebral Body Replacement System (K022563)
• Trabecular Metal Vertebral Body Replacement System (K031823)
• Trabecular Metal Vertebral Body Replacement System (K032527)

Submission Summary (Full Text)

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JUN 17 2005

Zimmer TMT

Trabecular Metal Vertebral Body Replacement Special 510(k) Premarket Notification

K05 1196
Page 1 of 2

## 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: | May 2, 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 |

The Trabecular Metal Vertebrai Body Replacement System is Device The Traocoural Motar va replacement for a single diseased or Description: designed to be 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 available to accommon 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.

The Zimmer TMT Trabecular Metal Vertebral Body Replacement Indications for Use: 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.

The device is unique in comparison to predicates for this Device Technological indication with regard to its geometry. The material has been Characteristics and used in cited predicates for other applications. The Zimmer TMT Comparison to Vertebral Body Replacement System is substantially equivalent Predicate Device:

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## (051196 to previously cleared components of this same system (K010378, K021025, K021967, K022563, K031823, and K032527). 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. . Metal Vertebral Bodv TMT Trabecular Conclusion:

The Zimmer Replacement System is substantially equivalent to the predicate devices identified in this premarket notification.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 2005

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

Re: K051196

Trade/Device Name: The Trabecular Metal Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 6, 2005 Received: June 7, 2005

Dear Ms. Halevi:

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. Iisting 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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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 Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stut Rurdu

Miriam C. Provost, Ph.D. 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): _____K051196 _______________________________________________________________________________________________________________________________________

The Trabecular Metal Vertebral Body Replacement System Device Name:

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 (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.

Prescription Use _ ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hupt Rhodes

Division of General, Restorative, and Neurological Devices

510(k) Number_