VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX

K042776 · Zimmer, Inc. · LPH · Nov 4, 2004 · Orthopedic

Device Facts

• Record ID: K042776
• Device Name: VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 4, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VerSys Beaded MidCoat Low Head Center 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, 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 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; straight, trapezoidal geometry; manufactured from Co-Cr-Mo alloy with sintered Co-Cr-Mo bead porous coating for biologic fixation. Features 12/14 Morse-type proximal neck taper for femoral head component attachment. Intended for surgical implantation in total or hemi-hip replacement procedures to restore joint function and alleviate pain. Device is a modification of the predicate VerSys Hip System; maintains fundamental scientific technology and materials.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Modular femoral stem; Co-Cr-Mo alloy construction; sintered Co-Cr-Mo bead porous coating for biologic fixation; 12/14 Morse-type proximal neck taper; trapezoidal proximal body geometry; uncemented.

Indications for Use

Indicated for total hip replacement or hemi-hip replacement in patients with severe hip pain/disability due to conditions including rheumatoid/osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, femoral neck fractures, congenital dysplasia, or failed previous prostheses. Hemi-hip replacement indicated for elderly/debilitated patients where total hip replacement 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 Beaded Hip Prosthesis (K973714)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the word "zimmer" with a stylized "Z" in a circle to the left of the word. The "Z" is in bold and is the only capitalized letter in the image. The rest of the word is in lowercase and in a bold font. The image is in black and white.

| NOV - 4 2004 | Summary of Safety and Effectiveness |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
| Contact Person: | Karen Cain<br>Manager, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | October 5, 2004 |
| Trade Name: | <i>VerSys</i> R Beaded MidCoat Low Head Center Hip<br>Prosthesis |
| Common Name: | Total hip prosthesis |
| Classification Name<br>and Reference: | Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis |
| | 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 MidCoat Low<br>Head Center Hip Prosthesis is a straight, 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 MidCoat Low Head Center Hip<br>Prosthesis is designed to achieve biologic fixation<br>to bone and is indicated for: |

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

Image /page/1/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white and appears to be a vector graphic.

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 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 modifications to the VerSvs Hip System Beaded Hip Prosthesis change neither the intended use nor the fundamental scientific technology of the device. Both devices are packaged and sterilized using the same materials and processes.

Non-clinical performance testing demonstrated that the device is equivalent to the predicate.

Comparison to Predicate Device:

Performance Data

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.

NOV - 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Cain Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K042776

Trade/Device Name: VerSys® Beaded MidCoat Low Head Center Hip Prothesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prostheses. Regulatory Class: II Product Code: LPH Dated: October 5, 2004 Received: October 6, 2004

Dear Ms. Cain:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sumed in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 17, in accordance with the provisions of the Federal Food, Drug, devices that have been recassion t require approval of a premarket approval application (PMA). and Oosmeter for ( 100 ) 100 ( 100 ) 100 ) 100 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 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.

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

## Page 2 - Ms. Karen Cain

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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

O Mark A. Mulkerson

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

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

## Indications for Use

510(k) Number (if known):

Device Name:

VerSys® Beaded MidCoat Low Head Center Hip Prosthesis

Indications for Use:

The VerSys Beaded MidCoat Low Head Center 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, 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 fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral 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)

Mark N. McSherry

1. Restorative. Division of Gen and Neurological Devices

Page 1 of 1

510(k) Number K042776