MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES

K030733 · Zimmer, Inc. · LPH · May 1, 2003 · Orthopedic

Device Facts

• Record ID: K030733
• Device Name: MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: May 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MAYO 12/14 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

Modular femoral stem for total hip arthroplasty; replaces hip joint. Collarless, wedge-shaped design; intended for cementless fixation via biological ingrowth into fiber metal pads and mechanical press fit into proximal femoral shaft. Used with variety of modular femoral heads. Implanted by orthopedic surgeons in clinical/OR setting. Provides structural support for hip joint; restores mobility; reduces pain. Features 12/14 Morse-type taper neck; available with or without HA/TCP coating.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular femoral stem; collarless, wedge-shaped geometry. Materials and manufacturing processes identical to predicates. Features fiber metal pads for biological ingrowth. Includes 12/14 Morse-type taper neck. Optional HA/TCP coating. Uncemented fixation.

Indications for Use

Indicated for cementless total hip replacement in skeletally mature individuals with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, slipped capital femoral epiphysis, fused hip, pelvic fracture, or 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 (K943230)
• VerSys Fiber Metal Taper Hip Prosthesis (K964769)
• Harris/Galante Hip System with Calcicoat Ceramic Coating (K980711)

Submission Summary (Full Text)

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| MAY - 1 2003 | Summary of Safety and Effectiveness |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
| Contact Person: | Laura D. Williams, RAC<br>Sr. Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 7, 2003 |
| Trade Name: | MAYO®* Conservative Hip Prosthesis |
| Common Name: | Total hip prosthesis |
| Classification Name and Reference: | Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis<br>21 CFR § 888.3358 |
| Predicate Devices: | MAYO Conservative Hip Prosthesis, manufactured<br>by Zimmer, K943230, cleared January 14, 1997<br><br>VerSys® Fiber Metal Taper Hip Prosthesis,<br>manufactured by Zimmer, K964769, cleared<br>February 13, 1997<br><br>Harris/Galante Hip System with Calcicoat®<br>Ceramic Coating, manufactured by Zimmer,<br>K980711, cleared November 12. 1998 |
| Device Description: | Like the predicate MAYO Hip, the MAYO 12/14 Hip<br>Prosthesis is a modular femoral stem intended to<br>replace the hip joint in total hip arthroplasty. It is<br>used with a variety of modular femoral heads. The<br>stem is collarless, wedge-shaped, and is intended<br>for use without bone cement. Fixation is achieved<br>by biological ingrowth into the fiber metal pads and<br>by mechanical press fit into the proximal femoral<br>shaft. |
| Intended Use: | The MAYO 12/14 Conservative Hip Prosthesis is<br>indicated for cementless use in skeletally mature<br>individuals undergoing primary surgery for total hip |
| | 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. |
| Comparison to Predicate Device: | The MAYO 12/14 Hip is packaged, manufactured<br>and sterilized using the same materials and<br>processes as the predicates. The MAYO 12/14 Hip<br>will be available with a 12/14 Morse-type taper<br>neck, and with or without HA/TCP coating. |
| Performance Data: | Non-clinical performance testing demonstrated that<br>the device is equivalent to the predicate. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAY = 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura D. Williams, RAC Sr. Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Re: K030733

Trade/Device Name: MAYO® Conservative Hip Prosthesis Regulation Number: 888.3358 Regulation Name: Hip joint/metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: March 7, 2003 Received: March 10, 2003

Dear Ms. Williams:

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 - Laura D. Williams

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Mark A. Millerson

Celia Witten, Ph.D., M.D. 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

Page 1 of 1

510(k) Number (if known):

长02,0733

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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div> <p>(Division Sign-Off)</p> </div> | |
|--------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------|
| | Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K030733 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |