ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM

K081007 · Zimmer, Inc. · KWA · May 6, 2008 · Orthopedic

Device Facts

• Record ID: K081007
• Device Name: ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: May 6, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. The femoral stem is for cementless use only.

Device Story

Modular, wedge-shaped femoral stem system; utilizes Kinectiv technology for independent adjustment of leg length and offset; facilitates soft tissue balancing and restoration of hip joint center of rotation. Implanted by orthopedic surgeons in clinical/OR settings. Provides mechanical structural support for hip joint replacement. Benefits patients by optimizing joint stability and accommodating diverse patient anatomies through modular neck options.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular, wedge-shaped femoral stem; Ti-6Al-4V titanium alloy plasma spray coating. Cementless fixation. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring total or hemi-hip replacement due to severe hip pain, disability from arthritis (rheumatoid, osteoarthritis, traumatic, polyarthritis), collagen disorders, avascular necrosis, femoral nonunion, congenital dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, failed prior endoprostheses, or acute femoral neck fractures. Hemi-hip replacement indicated for elderly/debilitated patients where total hip is contraindicated, irreducible fractures, high subcapital/comminuted fractures, or pathological fractures. Cementless use only.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology (K063251)

Submission Summary (Full Text)

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K081007 (P3

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## Summary of Safety and Effectiveness

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Benjamin C. Curson, CQE<br>Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | May 2, 2008 |
| Trade Name: | Zimmer® M/L Taper Hip Prosthesis with Kinectiv™<br>Technology System |
| Common Name: | Total Hip Prosthesis |
| Classification Name<br>and Reference: | KWA - Hip joint metal/metal semi-constrained with<br>uncemented acetabular shell, 21 CFR § 888. 3330 |
| Predicate Device: | Zimmer® M/L Taper Hip Prosthesis with Modular<br>Neck Technology, manufactured by Zimmer, Inc.,<br>K063251, cleared January 24, 2007. |
| Device Description: | The Zimmer M/L Taper Hip Prosthesis with<br>Kinectiv Technology System is a modular, wedge-<br>shaped stem that is coated with Ti-6A1-4V titanium<br>alloy plasma spray. |

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Intended Use:

Comparison to Predicate Device:

# K081007

The modular neck options allow for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of patient anatomies.

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

> Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; sccondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is packaged, manufactured, and stcrilized using the same materials and processes as its predicate. The subject device also has the same intended use and fixation methods as the predicate device.

Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv

Technology System met performance requirements and is as safe and effective as its predicate.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. % Mr. Benjamin C. Curson P.O. Box 708 Warsaw, Indiana 46581-0708 MAY - 6 2008

K081007 Re: Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prothesis Regulatory Class: Class III Product Code: KWA, JDL, LWJ, LZO, MEH Dated: April 4, 2008 Received: April 8, 2008

Dear Mr. Curson:

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.

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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Page 2 - Mr. Benjamin C. Curson, CQE

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark H. Millman

Mark N. Melkerson 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: K081007

#### Device Name:

Zimmer® M/L Taper Hip Prosthesis with Kinectiv™Technology System

#### Indications for Use:

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The femoral stem is for cementless use only.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Rf. Qal - Es mkn

(Division Sign-Off)

Division of General, Restorative. and Neurological Devices

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510(k) Number_