ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY

K063251 · Zimmer, Inc. · KWA · Jan 24, 2007 · Orthopedic

Device Facts

• Record ID: K063251
• Device Name: ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
• Applicant: Zimmer, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Jan 24, 2007
• Decision: SESE
• Submission Type: Traditional
• 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. This femoral stem is for cementless use only.

Device Story

Modular, wedge-shaped femoral stem for cementless hip arthroplasty; features modular neck technology to facilitate soft tissue balancing, leg length equalization, and hip joint center of rotation restoration. Device implanted by orthopedic surgeons in clinical/hospital settings. Modular design allows intraoperative optimization of offset and joint stability based on patient anatomy. Coated with commercially pure titanium alloy plasma spray; optional Calcicoat Ceramic Coating. Benefits include improved anatomical reconstruction and joint stability.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Modular, wedge-shaped femoral stem; cementless fixation; commercially pure titanium alloy plasma spray coating; optional Calcicoat Ceramic Coating. Modular neck component. No software or electronic components.

Indications for Use

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

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 (K032726)
• Profemur TL Hip Stem (K060358)
• Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating (K042337)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness

K063251

Submitter:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate Device:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 JAN 2 4 2007

Dalene T. Binkley, RAC Senior Associate, Regulatory Affairs Telephone: [phone] Fax: [phone]

January 23, 2006

Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology

Total Hip Prosthesis

1. KWA - Hip joint metal/metal semi-constrained with uncemented acetabular shell, 21 CFR § 888. 3330

2. JDL - Hip joint metal/metal semi-constrained with cemented acetabular shell, 21 CFR & 888. 3320

3. LPH - Prosthesis, hip, semi-constrained metal/polymer porous uncemented, 21 CFR & 888. 3358

4. LWJ - Prosthesis, hip, semi-constrained metal/polymer uncemented (hemi-hip), 21 CFR § 888. 3360

5. MEH - Prosthesis, hip, semi-constrained uncemented metal polymer, non-porous, calcium phosphate, 21 CFR § 888. 3353

Zimmer® M/L Taper Hip Prosthesis, manufactured by Zimmer, Inc., K032726, cleared October 22, 2003

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K063251

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Profemur TL Hip Stem manufactured by Wright Medical Technology, Inc., K060358, cleared May 10, 2006

Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating, manufactured by Zimmer, Inc., K042337, cleared November 4, 2004

The Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology is a modular, wedgeshaped stem that is coated with commercially pure titanium alloy plasma spray that is available with and without Calcicoat Ceramic Coating. This stem is designed for cementless use only.

The modular neck option allows 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 different patients' 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; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

### Device Description:

Intended Use:

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063251

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# Comparison to Predicate Device:

## Performance Data (Nonclinical and/or Clinical):

The M/L Taper Hip Prosthesis with Modular Neck Technology is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices.

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Modular Neck Technology met performance requirements and is as safe and effective as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. c/o Ms. Dalene T. Binkley Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

JAN 2 4 2007

Re: K063251

Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL, LPH, LWJ, MEH, LZO Dated: October 26, 2006 Received: October 27, 2006

Dear Ms. Binkley:

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. Iisting 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

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### Page 2 - Ms. Dalene T. Binklev

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Souall 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,

for

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K06 3251

## Indications for Use

## 510(k) Number (if known):

#### Device Name:

Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology

#### Indications for 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.

This 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)

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

currence of CDRH, Office of Device Evaluation (ODE)

(Division Sigu-On)
Division of General, Restorative,
and Neurological Devices

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**510(k) Number** 1106325