VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS

K030079 · Zimmer, Inc. · LPH · Feb 5, 2003 · Orthopedic

Device Facts

• Record ID: K030079
• Device Name: VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VerSys® Beaded Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for: 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, protrusion 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 fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.

Device Story

Modular femoral stem prosthesis for total or hemi-hip replacement; manufactured from Co-Cr-Mo alloy with sintered Co-Cr-Mo bead porous coating for biologic fixation. Features trapezoidal proximal body geometry and 12/14 Morse-type proximal neck taper for femoral head component attachment. Used by orthopedic surgeons in clinical/surgical settings to replace diseased or damaged hip joints. Device provides structural support and articulation, aiming to restore hip function and alleviate pain in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular femoral stem; Co-Cr-Mo alloy construction; sintered Co-Cr-Mo bead porous coating for biologic fixation; trapezoidal proximal body geometry; 12/14 Morse-type proximal neck taper. Mechanical device; 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, femoral fractures (nonunion, acute, pathological, subcapital, comminuted), congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, previous fusion, or failed prior hip components. Hemi-hip replacement indicated for elderly/debilitated patients where total hip replacement is contraindicated.

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

• VerSys Hip System Beaded Hip Prosthesis (K973714)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The font is sans-serif and the color is black.

## { 06 Summary of Safety and Effectiveness

FEB 0 5 2003

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| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fred McClure, RAC<br>Sr. Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | January 8, 2003 |
| Trade Name: | <i>VerSys</i> ® Beaded Fullcoat Bowed Revision Hip<br>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 Device: | <i>VerSys</i> Hip System Beaded Hip Prosthesis,<br>manufactured by Zimmer, K973714, cleared<br>December 24, 1997 |
| Device Description: | Like its predicate, the <i>VerSys</i> Beaded Fullcoat<br>Bowed Revision Hip Prosthesis is a modular<br>femoral stem manufactured from Co-Cr-Mo alloy<br>and has a sintered Co-Cr-Mo alloy bead porous<br>surface coating. The prosthesis features a 12/14<br>Morse-type proximal neck taper to mate with the<br>corresponding 12/14 bore of a femoral head<br>component. Proximal body geometry of the<br>prosthesis is trapezoidal. |
| Intended Use: | The <i>VerSys</i> ® Beaded Hip Prosthesis is designed to<br>achieve biologic fixation to bone and is indicated<br>for: |
| | Total hip replacement for the following: severe hip<br>pain and disability due to rheumatoid arthritis,<br>osteoarthritis, traumatic arthritis, polyarthritis, |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

Fred McClure, RAC Sr. Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K030079

Trade/Device Name: VerSys® Beaded Fullcoat Bowed Revision 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: January 8, 2003 Received: January 9, 2003

Dear Mr. McClure:

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

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Page 2 – Mr. Fred McClure

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. 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). 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,

b. Mark M. Milliman

Celia M. 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):

030079

Device Name:

VerSys® Beaded Fullcoat Bowed Revision Hip Prosthesis

## Indications for Use:

The VerSys Beaded Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:

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, protrusion 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 fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> for </div> <div> (Division Sign-Off) </div> |
|---------------------------------------|---------------------------------------------------------------------|
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K030079 |
| Prescription Use (Per 21 CFR 801.109) | Yes |
| | OR |
| | Over-The-Counter Use (Optional Format 1-2-96) No |