TRABECULAR METAL (TM) FUSION DEVICE

K111119 · Zimmer Spine, Inc. · ODP · Nov 23, 2011 · Orthopedic

Device Facts

• Record ID: K111119
• Device Name: TRABECULAR METAL (TM) FUSION DEVICE
• Applicant: Zimmer Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trabecular Metal™ Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

Device Story

Trabecular Metal™ Fusion Device is a porous tantalum intervertebral body fusion implant; designed for cervical spine stabilization. Device features ripple-patterned superior/inferior surfaces and central hole for bone graft; includes central anterior slot for inserter interface. Implanted via anterior approach by surgeons to maintain disc height and facilitate fusion; used in conjunction with supplemental fixation systems and autogenous bone graft. Device provides structural support to prevent vertebral collapse in patients with degenerative disc disease. Available in various cross-sectional sizes and lordotic/non-lordotic configurations; current submission adds 4mm, 11mm, and 12mm height options.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static axial compression, dynamic axial compression, static torsion, dynamic torsion, static compression shear, and dynamic compression shear testing per ASTM F2077-03. No clinical data presented.

Technological Characteristics

Material: Porous tantalum (Trabecular Metal). Design: Intervertebral body fusion device with ripple-patterned surfaces and central bone graft aperture. Dimensions: Various cross-sections (11x11mm, 11x14mm, 14x14mm) and heights (4-12mm). Configuration: 7° lordotic and 0° non-lordotic. Mechanical testing standard: ASTM F2077-03.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1, confirmed by history and radiographic studies, following six weeks of failed non-operative treatment.

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

• Zimmer Trabecular Metal™ Fusion Device (K103033)
• Depuy Bengal™ Intervertebral Fusion Device (K081917)

Submission Summary (Full Text)

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NOV 2 3 2011

## 510(k) Summary

| Submitter: | Zimmer Spine<br>5301 Riata Park Court<br>Austin, TX 78727 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Author: | Jennifer Tribbett<br>Senior Regulatory Affairs Specialist |
| Contact Person: | Jennifer Tribbett<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | November 22, 2011 |
| Trade Name: | Trabecular Metal™ Fusion Device |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name and<br>Reference: | Intervertebral Body Fusion Device<br>21 CFR § 888.3080, ODP |

#### DEVICE DESCRIPTION

The Trabecular Metal™ Fusion Device is an interbody fusion device comprised wholly of porous tantalum Trabecular Metal. The Trabecular Metal™ Fusion Device is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrae onto another.

The Trabecular Metal™ Fusion Device is currently offered in three cross sectional sizes (11x11mm, 11x14mm, and 14x14mm) and in 7° lordotic and 0° non-lordotic configurations. Height options are available in 5, 6, 7, 8, 9, and 10mm sizes. The present 510(k) premarket notification seeks to extend the product line by offering three additional height options of 4, 1 l and 12mm sizes to the existing TM-S Fusion Device implant system.

The superior and inferior surfaces of the device have a pattern of ripples and a central hole in the device extending in the superior-inferior direction for placement of bone graft. Additionally, the proposed system contains a central slot on the anterior surface to allow interface with a central inserter.

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### INDICATIONS FOR USE

The Trabecular Metal™ Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

# DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE(S)

The Trabecular Metal™ Fusion Device was shown to be substantially equivalent to a legally marketed predicate device. The predicate device selected for use, material, technological maracteristics and basic principles of operation was the Zimmer Trabecular Metal™ Fusion Device (K103033). The predicate device selected for footprint (height) was the Depuy Bengal™ Intervertebral Fusion Device (K081917).

The Trabecular Metal Fusion Device has the identical material as the previously cleared Zimmer Trabecular Metal Fusion Device. The intended use and indications for use of the subject device are identical to that of the Zimmer Trabecular Metal Fusion Device. The sizes of the device in the current submission are identical to the Depuy Bengal Intervertebral Fusion Device.

# PERFORMANCE DATA

According to the FDA's "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", the following tests are recommended for this type of device: Static Axial Compression, Dynamic Axial Compression, Static Torsion, Dynamic Torsion, Static Compression Shear, Dynamic Compression Shear and Subsidence. Among these tests, subsidence is not affected by the height of an interbody device, given the same cross-section and profile design.

Therefore, mechanical testing was performed on the Trabecular Metal Fusion Device which included Static Axial Compression, Dynamic Axial Compression, Static Torsion, Dynamic Torsion, Static Compression Shear and Dynamic Compression Shear all per ASTM F2077-03. The results of testing and analyses conducted demonstrate that the proposed system is substantially equivalent to the Zimmer Trabecular Metal Fusion Device in terms of mechanical performance.

## CONCLUSION

The additional sizes of the Trabecular Metal™ Fusion Device are substantially equivalent to the Zimmer Trabecular Metal Fusion Device with respect to intended use/indications for use, material, technological characteristics and basic principles of operation. As demonstrated by supporting performance data, the introduction of new sizes does not present any new issues of safety or effectiveness.

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# 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 consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

NOV 2 3 2011

Zimmer Spine, Inc. % Ms. Jennifer Tribbett Senior Regulatory Affairs Specialist 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K111119

Trade/Device Name: Trabecular Metal" Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 14. 2011 Received: October 17, 2011

Dear Ms. Tribbett:

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

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Page 2 - Ms. Jennifer Tribbett

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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Eune Keith

fo 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):

Device Name: Trabecular Metal™ Fusion Device

Indications for Use:

The Trabecular Metal Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

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)

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

510(k) Number___K111119