MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05

K061461 · Zimmer, Inc. · LPH · Dec 20, 2006 · Orthopedic

Device Facts

• Record ID: K061461
• Device Name: MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAYO Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Device Story

MAYO Conservative Hip Prosthesis is a modular femoral stem for total hip arthroplasty; replaces hip joint. Features 12/14 Morse-type taper; compatible with modular femoral heads. Collarless, wedge-shaped design; intended for cementless fixation via mechanical press fit into proximal femoral shaft and biological ingrowth into fiber metal pads. Available with or without Calcicoat (HA/TCP) ceramic coating. Modified version of predicate to accommodate smaller patient anatomies. Used by orthopedic surgeons in clinical settings. Provides structural support for hip joint; restores mobility; reduces pain.

Clinical Evidence

No clinical data provided; bench testing only. Engineering evaluations demonstrated equivalence to predicate.

Technological Characteristics

Modular femoral stem; 12/14 Morse-type taper; collarless, wedge-shaped geometry. Fixation via mechanical press fit and fiber metal pads for biological ingrowth. Optional Calcicoat (HA/TCP) ceramic coating. Materials and manufacturing processes identical to predicate.

Indications for Use

Indicated for skeletally mature individuals undergoing primary total hip replacement. Diagnostic indications: severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, pelvic fracture, and diastrophic variant.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• MAYO Conservative Hip Prosthesis (K030733)

Submission Summary (Full Text)

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# DEC 2 0 2006

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## KO61461 Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | May 24, 2006 |
| Trade Name: | <i>MAYO</i> ^® Conservative Hip Prosthesis |
| Common Name: | Total Hip Prosthesis |
| Classification Name<br>and Reference: | Prosthesis, Hip, Semi-constrained Metal/Polymer.<br>Porous Uncemented,<br>21 CFR § 888.3358 |
| Predicate Device: | <i>MAYO</i> Conservative Hip Prosthesis, manufactured<br>by Zimmer, Inc., K030733, cleared May 1, 2003 |
| Device Description: | Like its predicate, the modified <i>MAYO</i> Conservative<br>Hip Prosthesis is a modular femoral stem intended<br>to replace the hip joint in total hip arthroplasty. It is<br>identical to its predicate in that it features a 12/14<br>Morse-type taper and uses the same variety of<br>modular femoral heads. It differs only in overall<br>size where the design is intended to address smaller<br>patient anatomies. As with the predicate, the<br>proposed stem is collarless, wedge-shaped, and is<br>designed for use without bone cement. Fixation is<br>achieved by mechanical press fit into the proximal<br>femoral shaft and by biological ingrowth into the<br>fiber metal pads. As with the predicate, the<br>proposed device is available with and without<br><i>Calcicoat</i> ^® Ceramic Coating (HA/TCP). |
| Intended Use: | The <i>MAYO</i> Conservative Hip Prosthesis is indicated<br>for cementless use in skeletally mature individuals<br>undergoing primary surgery for total hip |

*Trademark of Mayo Foundation

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| | replacement. Diagnostic indications include severe<br>hip pain and disabilities due to rheumatoid arthritis.<br>osteoarthritis, traumatic arthritis, polyarthritis,<br>slipped capital femoral epiphysis, fused hip, fracture<br>of the pelvis, and diastrophic variant. |
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| Comparison to Predicate Device: | The modifications to the MAYO hip change neither<br>the intended use nor the fundamental scientific<br>technology of the device. It is packaged,<br>manufactured and sterilized using the same<br>materials and processes. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Engineering evaluations demonstrated that the<br>device is equivalent to the predicate. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for |

this device.

* Trademark of Mayo Foundation

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. % Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

DEC 2 0 2006

Re: K061461 Trade/Device Name: MAY0®* Conservative Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: December 7, 2006 Received: December 8, 2006

Dear Ms. Jenks:

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

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Page 2 - Ms. Patricia Jenks

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 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 N. Melkerson

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

#### K061461 510(k) Number (if known):

### Device Name:

MAYO®* Conservative Hip Prosthesis

### Indications for Use:

The MAYO Conservative Hip Prosthesis is indicated for cementless use in skeletally mature individuals undergoing primary surgery for total hip replacement. Diagnostic indications include severe hip pain and disabilities due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

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, Offic lice Evaluation (ODE)

, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

* Trademark of Mayo Foundation

**510(k) Number** K061461 Page 1 of 1