TRABECULAR METAL PRIMARY HIP PROSTHESIS

K051491 · Zimmer, Inc. · LPH · Jun 30, 2005 · Orthopedic

Device Facts

• Record ID: K051491
• Device Name: TRABECULAR METAL PRIMARY HIP PROSTHESIS
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Trabecular Metal Primary Hip Prosthesis is a single-use, wedge-shaped implant for hip joint replacement. Designed for cementless use; features circumferential Trabecular Metal coating on proximal body for biological fixation. Offered in various sizes with standard and extended neck offsets to accommodate patient anatomy. Used by orthopedic surgeons in clinical settings for total or hemi-hip arthroplasty. Device replaces damaged hip joint components to alleviate pain and restore function. No clinical data required; non-clinical testing confirms safety and effectiveness equivalent to predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance testing.

Technological Characteristics

Cementless, wedge-shaped hip prosthesis. Features circumferential Trabecular Metal coating on proximal body for biological fixation. Available in multiple sizes with standard and extended neck offsets. Single-use implant.

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 neck fractures, congenital dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or failed prior hip surgery. Hemi-hip replacement indicated for elderly/debilitated patients where total hip is contraindicated or for specific fracture types.

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 - Fiber Metal Taper Hip Prosthesis (K964769)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the word "zimmer" in bold, black font. To the left of the word is a circle with a bold, black letter "Z" inside. The letter "Z" is stylized with sharp angles and thick lines. The overall design appears to be a logo or brand mark.

## Summary of Safety and Effectiveness

## JUN 3 0 2005

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley, RAC<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | June 24, 2005 |
| Trade Name: | Trabecular Metal™ Primary Hip Prosthesis |
| Common Name: | Total Hip Prosthesis |
| Classification Name<br>and Reference: | LPH<br>21 CFR § 888.3358 |
| Predicate Device: | VerSys™ Hip System - Fiber Metal Taper Hip<br>Prosthesis, manufactured by Zimmer, Inc.,<br>K964769, cleared February 13, 1997 |
| Device Description: | The Trabecular Metal Primary Hip Prosthesis is<br>intended to be a single use only implant that is used<br>to replace a hip joint.<br><br>The wedge-shaped prosthesis is designed for<br>cementless use and is circumferentially bonded with<br>Trabecular Metal over the proximal body region for<br>biological fixation. The hip is offered in a broad<br>range of sizes designed to accommodate varying<br>patient anatomy with standard and extended neck<br>offsets. |
| Intended Use: | Total hip replacement for the following: severe hip<br>pain and disability due to rheumatoid arthritis,<br>osteoarthritis, traumatic arthritis, polyarthritis,<br>collagen disorders, avascular necrosis of the<br>femoral head, nonunion of previous fractures of the<br>femur; congenital hip dysplasia, protrusio acetabuli,<br>slipped capital femoral epiphysis; disability due to |

{1}------------------------------------------------

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 Trabecular Metal Primary Hip Prosthesis is packaged, manufactured, and sterilized using the same materials and processes as the predicate device. The subject device also has the same intended use and fixation methods as the predicate device.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the Trabecular Metal Primary Hip Prosthesis is as safe and effective as its predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

JUN 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dalene T. Binkley, RAC Senior Associate, Regulatory Affairs Zimmer Incorporated P. O. Box 708 Warsaw, Indiana 46581-0708

Re: K051491

K031491
Trade/Device Name: Trabecular Metal™ Primary Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: June 03, 2005 Received: June 06, 2005

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regary to regars and the Medical Device Amendments, or to conninered pror to May 20, 1977)
devices that have been reclassified in accordance with the provisions of the Federal Food, DNA de vices that have been require approval of a premarket approval application (PMA). alla Cosmetic Free (110) that so device, subject to the general controls provisions of the Act. The r ou may, mercere, mance and act include requirements for annual registration, listing of gencial controld provisioning 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 If your device is exassined controls. Existing major regulations affecting your device can may or subject to back access 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 I least of advisou that I Dris brisean that your device complies with other requirements of the Act that I Dri has made a aond regulations administered by other Federal agencies. You must or any I ederal bithe 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 CFR Part 807), adomig (21 CFR Part 820); and if applicable, the electronic 101th m and quants of oversions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Dalene T. Binkley, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hankeling your averal equivalence of your device to a legally premarket nothcation. The PDA midning of substance vice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your act [phone]. Also, please note the regulation entitled, p conlier the Office of Complance at (110) = i = = = = = = = = "Misbranding by relective to premarker noulities under the Act from the Division of Small other general Information on your response in to toll-free number [phone] or and index html Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely, yours,

Miriam C. Provost, Ph.D.

riam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Indications for Use

# 510(k) Number (if known): KOSTY9 |

Device Name:

Trabecular Metal™ Primary Hip Prosthesis

#### Indications for Use:

Total hip replacement for the following: severe hip pain and disability due to rheumatoid I otal hip replacement for the forlowing: 6078.0 the read as orders, avascular necrosis
arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, arthrills, osteballinitis, traintatio artifical poryal and the femur; congenital hip dysplasia, of the lemoral nead, nonumon of provious navisis; disability due to previous fusion;
protrusio acetabuli, slipped capital femoral epiphysis; disability of a flusted astronic protrusio acetabuli, shpped capital temoral opplify only somponents in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debiliated Hemi-hip replacement is contraindicated; irreducible fractures in which patients when a total inp replacement is contralized, or in the subcapital fractures and comminuted adequate fractures in the aged; nonunion of femoral neck fractures; secondary avasculars and femoral neck fractures in the aged, nonanon of formoral neck, and osteoarthritis in which the femoral head is primarily affected.

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, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------------------------------|-------------|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K051491 |
| | Page 1 of 1 |

0009