ZIMMER TRABECULAR METAL TOTAL ANKLE

K120906 · Zimmer, Inc. · HSN · Aug 24, 2012 · Orthopedic

Device Facts

• Record ID: K120906
• Device Name: ZIMMER TRABECULAR METAL TOTAL ANKLE
• Applicant: Zimmer, Inc.
• Product Code: HSN · Orthopedic
• Decision Date: Aug 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint. The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: - Rheumatoid arthritis. - Post-traumatic arthritis. - Degenerative arthritis. This device is intended for cemented use only.

Device Story

Bicondylar total ankle replacement system; designed to preserve motion and restore kinematics by mimicking natural ankle joint truncated cone shape. Talar component: wrought Cobalt Chrome Molybdenum (CoCrMo) alloy diffusion bonded to Trabecular Metal surface via Titanium interlayer. Tibial component: Tivanium (Ti-6Al-4V) baseplate diffusion bonded to Trabecular Metal surface with modular Prolong Highly Crosslinked Polyethylene (HXLPE) insert. Used in orthopedic surgery for ankle arthroplasty; implanted by surgeons. Provides mechanical replacement of articulating surfaces to reduce pain and restore alignment/mobility in patients with arthritis.

Clinical Evidence

No clinical data provided. Evidence based on non-clinical bench testing, including fatigue analysis, wear evaluation, contact area/stress evaluation, constraint evaluation, range of motion testing, and MRI compatibility testing per ASTM F2665 and FDA guidance for metallic surfaces.

Technological Characteristics

Bicondylar semi-constrained cemented prosthesis. Materials: Wrought CoCrMo (Zimaloy), Ti-6Al-4V (Tivanium), commercially pure Titanium, and Highly Crosslinked Polyethylene (Prolong). Design features Trabecular Metal porous surface for bone apposition. Tested per ASTM F2665. Sterilization method not specified.

Indications for Use

Indicated for patients requiring total ankle replacement in primary or revision surgery due to rheumatoid, post-traumatic, or degenerative arthritis. Intended for cemented use only.

Regulatory Classification

Identification

An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Alvine Total Ankle Prosthesis (Agility) (K920802, K020541)
• Salto Talaris Total Ankle Prosthesis (K060544)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a sans-serif font.

K120906

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

AUG 2 4 2012

## 510(k) Summary

Sponsor:

Contact Person:

Date:

Trade Name:

Product Code / Device:

Regulation Number / Description:

Predicate Device:

Device Description:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Rebecca Dill Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone]

August 21, 2012

Zimmer® Trabecular Metal™ Total Ankle

HSN - Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

21 CFR § 888.3110 - Ankle Joint metal/polymer semi-constrained cemented prosthesis

Alvine Total Ankle Prosthesis (Agility), manufactured by Depuy Orthopaedics, Inc., K920802, cleared December 17, 1992 and K020541, cleared May 20, 2002. Salto Talaris Total Ankle Prosthesis, manufactured by Tornier Inc., K060544, cleared November 13, 2006.

The Zimmer Trabecular Metal Total Ankle is an implant and instrument system designed to preserve motion in arthritic ankle patients. It is a semiconstrained device intended for the replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury.

The Zimmer Trabecular Metal Total Ankle is a bicondylar system. The articular surfaces of the implants are designed to mimic the truncated cone

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

K120906

ের প্রতি

shape of the natural ankle joint, thereby reproducing normal ankle joint kinematics.

The talar component is machined from a wrought Cobalt Chrome Molybdenum (CoCrMo) Alloy (Zimaloy®) diffusion bonded to a Trabecular Metal™ surface via an interlayer of commercially pure Titanium.

The tibial component consists of a Tivanium® (Ti-6Al-4V) tibial baseplate diffusion bonded to a Trabecular Metal™ surface and a modular insert of Prolong® Highly Crosslinked Polyethylene (HXLPE).

## Intended Use:

Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.

The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:

- . Rheumatoid arthritis.
- Post-traumatic arthritis. .
- Degenerative arthritis. .

This device is intended for cemented use only.

The substantial equivalence of the Zimmer Trabecular Metal Total Ankle to the Alvine Total Ankle Prosthesis (Agility) and the Salto Talaris Total Ankle Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization method, classification name and materials used.

Non-Clinical Performance and Conclusions:

The following non-clinical testing was performed. 1. Testing per FDA's guidance document

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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

3/3

"Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement".

2. Testing per ASTM F2665 "Standard Specification for Total Ankle Replacement Prosthesis".

3. MRI compatibility testing for tibial and talar components.

4. Range of Motion of the Zimmer Trabecular Metal Total Ankle.

5. Fatigue Analysis of the Cemented Zimmer Trabecular Metal Modular Total Ankle Replacement System.

6. Wear Evaluation of the Zimmer Trabecular Metal Modular Total Ankle Replacement System.

7. Zimmer Trabecular Metal Modular Total Ankle Replacement System Contact Area / Contact Stress Evaluation. ·

8. Zimmer Trabecular Metal Modular Total Ankle System Constraint Evaluation

Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device. ·

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle-like symbol composed of three curved lines.

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

AUG 2 4 2012

Zimmer, Inc. % Ms. Rebecca Dill P.O. Box 708 Warsaw, IN 46581

Re: K120906

Trade/Device Name: Zimmer Trabecular Metal Total Ankle Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HSN Dated: August 15, 2012 Received: August 16, 2012

Dear Ms. Dill:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

forth in the quality systems (OS) 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 yours,
Mark A. Millman

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

Enclosure

{5}------------------------------------------------

# Indications for Use

# 510(k) Number (if known): |( | 20 906

#### Device Name:

Zimmer® Trabecular Metal™ Total Ankle

Indications for Use:

Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.

The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:

- . Rheumatoid arthritis.
- Post-traumatic arthritis. .
- Degenerative arthritis. .

This device is intended for cemented use only.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ar

Page 1 of 1

(Division Sign-Oft) Division of Surgical, Orthopedic, ano Restorantes Devices

510(k) Number K120906

12