TM-400 DEVICE

K120203 · Zimmer Trabecular Metal Technology, Inc. · MAX · Jun 15, 2012 · Orthopedic

Device Facts

• Record ID: K120203
• Device Name: TM-400 DEVICE
• Applicant: Zimmer Trabecular Metal Technology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TM-400 device 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 TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft. The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

Device Story

TM-400 is an oval-shaped, porous tantalum intervertebral body fusion and vertebral body replacement device. Implanted surgically in the thoracolumbar spine to replace collapsed/damaged vertebrae or fuse adjacent bony surfaces in DDD patients. Features include patterned teeth on superior/inferior surfaces for initial stability and slots for insertion instrumentation. Used with supplemental internal fixation and bone graft (autograft/allograft). Provides structural support to the anterior column of the spine; facilitates fusion. Available in various heights, cross-sections, and lordotic angles (7 and 13 degrees) to match patient anatomy.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. Testing included static and dynamic axial compression (ASTM F2077-03), static and dynamic torsion (ASTM F2077-01), expulsion, and subsidence (ASTM F2267-04 & F2077). Results demonstrated the system meets predetermined mechanical performance requirements.

Technological Characteristics

Material: Trabecular Metal Porous Tantalum. Form factor: Oval-shaped implant with surface teeth and insertion slots. Lordotic angles: 7 and 13 degrees. Mechanical testing standards: ASTM F2077-03, F2077-01, F2267-04. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement (T1-L5) due to tumor or trauma (fracture), or intervertebral body fusion (L2-S1) for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD patients must have discogenic back pain, radiographic confirmation, and 6 months of failed non-operative treatment. Requires supplemental internal fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• TM-400 Device (K052950, K031823, K010378)
• Instrumentation for TM-400 (K093127)
• Zimmer Spine, Inc. Ardis® Interbody System (K073202)
• Biomet Enclave (K081636)
• Orthofix Pillar AL (K082235)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN 1 5 2012

### 510(k) Summary

| Submitter: | Zimmer Trabecular Metal Technology, Inc.<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: | June 6, 2012 |
| Trade Name: | TM-400 Device |
| Common Name:<br>Replacement<br>Classification Name: | Intervertebral body fusion device & Spinal Vertebral Body<br>Device<br>Intervertebral body fusion device, 21 CFR § 888.3080,<br>Spinal intervertebral body fixation orthosis, 21 CFR § 888.3060 |

Device Panel/Product Code:Orthopedic MAX & MQP

### Device Description:

The TM-400 Device is an oval shaped ALIF device for interbody fusion of the anterior column of the spine. The TM-400 Device is currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as an interbody fusion device. TM-400 Device is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. TM-400 implants are also available in two lordotic angles 7 degree and 13 degree. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. The device also has slots to mate with the insertion instrument. The TM-400 device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system are fabricated from surgical grade stainless steel and other applicable materials.

### Indications for Use:

The TM-400 device 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 TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft.

The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the

{1}------------------------------------------------

disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

### Device Technological Characteristics and Comparison to Predicate Device(s):

The TM-400 Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this TM-400 Device as a VBR (K052950, K031823, K010378 and, for the instrumentation, K093127), the Zimmer Spine, Inc. Ardis® Interbody System cleared under K073202, the Biomet Enclave cleared under K081636 and the Orthofix Pillar AL cleared under K082235.

The TM-400 Device has the identical material as previously cleared devices. The intended use and indications for use of the subject device are similar to those of its predicate devices. The sizes, design features and overall geometry of the device in the current submission are similar to the cleared predicate devices.

There are no significant differences between the TM-400 Device and the predicate devices currently being marketed that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety or efficacy. The subject system is similar to its predicate devices with respect to intended use/indications for use, material, technological characteristics and basic principles of operation.

### Performance Data:

Mechanical testing was performed on the TM-400 Device as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. The tests that were performed and the relevant ASTM Standards are as follows:

| Mechanical Tests | ASTM Standard |
|---------------------------|------------------|
| Static Axial Compression | F2077-03 |
| Dynamic Axial Compression | F2077-03 |
| Static Torsion | F2077-01 |
| Dynamic Torsion | F2077-01 |
| Expulsion | N/R |
| Subsidence | F2267-04 & F2077 |

The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance.

### Substantial Equivalence:

The TM-400 Device is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation as demonstrated by the supporting performance testing data.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 5 2012

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

Re: K120203

Trade/Device Name: TM-400 Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: May 21, 2012 Received: May 29, 2012

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

{3}------------------------------------------------

### Page 2 - Ms. Kathleen Rutherford

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 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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark McMillan

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

Enclosure

{4}------------------------------------------------

### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TM-400 Device

Indications for Use:

The TM-400 device 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 TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft.

The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-SI. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

Prescription Use X (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)

Page 1 of 1

:

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

K120203 510(k) Number_