TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET

K093127 · Zimmer Trabecular Metal Technology · MQP · Mar 4, 2010 · Orthopedic

Device Facts

• Record ID: K093127
• Device Name: TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
• Applicant: Zimmer Trabecular Metal Technology
• Product Code: MQP · Orthopedic
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2

Intended Use

The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in 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

Instrumentation set for implantation of Trabecular Metal Vertebral Body Replacement (VBR) system. Includes provisionals for sizing surgical site and straight inserters/tamps for implant placement. Used in thoracolumbar (T1-L5) surgical cases via anterior or lateral lumbar approach. Operated by surgeons in clinical/OR settings. Facilitates accurate positioning of porous tantalum VBR implants to replace damaged vertebral bodies. Mechanical tools only; no electronic or software components.

Clinical Evidence

Bench testing only. Mechanical performance testing and analyses conducted to demonstrate that the worst-case instruments meet predetermined mechanical requirements.

Technological Characteristics

Instrumentation set composed of 17-4 stainless steel. Includes provisionals for sizing and inserters/tamps for implant delivery. Manual surgical tools; no energy source, connectivity, or software.

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.

Submission Summary (Full Text)

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93127

#### 510(k) Summary

| Submitter: | Zimmer Trabecular Metal Technology, Inc.<br>MAR - 4 2010<br>10 Pomeroy Road<br>Parsippany, New Jersey 07054 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Rutherford<br>Associate Director, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | September 15, 2009 |
| Trade Name: | Trabecular MetalTM Vertebral Body Replacement System<br>Instrumentation Set |
| Common Name: | Vertebral Body Replacement Device Instrumentation Set |
| Classification Name and<br>Reference: | Spinal Intervertebral Body Fixation Orthosis<br>21 CFR § 888.3060, MQP |

#### DEVICE DESCRIPTION

The existing, commercially available Trabecular Metal Vertebral Body Reconstruction System is intended for use in thoracolumbar (TI-L5) surgical cases to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Reconstruction System is wholly comprised of Trabecular Metal Porous Tantalum (tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.

The Trabecular Metal Vertebral Body Replacement System Instrumentation Set which is the subject of this premarket notification is intended for use in these thoracolumbar surgical cases and facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system. The provisionals size the surgical site in order to determine the appropriate TM-400 implant size. The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach. All instruments included in the set are made from 17-4 stainless steel.

Zimmer TMT. Inc. Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation

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#### INDICATIONS FOR USE

The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in 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 CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE(S)

Zimmer Trabecular Metal Technology, Inc. has submitted documentation demonstrating the substantial equivalence of the proposed instrument set to its predicate devices. The subject instrument set is similar to its predicate devices with respect to intended use/indications for use, materials, and basic principles of operation.

### PERFORMANCE DATA

The results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance.

## SUBSTANTIAL EQUIVALENCE

The redesigned Trabecular Metal™ Vertebral Body Replacement System Instrument Set is substantially equivalent to the predicate instruments with respect to intended use/indications for use, technological characteristics and basic principles of operation. As demonstrated by supporting tests and descriptions, this minor redesign does not present any new issues of safety or effectiveness.

Zimmer TMT, Inc.

Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head facing to the left.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR - 4 2010

Zimmer Trabecular Metal Technology, Inc % Ms. Kathleen Rutherford Associate Director, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054

Re: K093127

Trade/Device Name: Trabecular Metal Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: February 23, 2010 Received: February 25, 2010

Dear Ms. Rutherford:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Kathleen Rutherford

device-related adverse events) (21 CFR 803); 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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Milliken

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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#### Indications for Use

510(k) Number (if known): K0913127

Device Name: Trabecular Metal™ Vertebral Body Replacement System Instrument Set

Indications for Use:

The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable vertebral body duc 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 X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K093127

Zimmer TMT, Inc. Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation

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