VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS

K061786 · Zimmer, Inc. · LPH · Jul 24, 2006 · Orthopedic

Device Facts

• Record ID: K061786
• Device Name: VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Cementless, straight, modular femoral stem for total or hemi-hip replacement; features trapezoidal geometry, 12/14 Morse-type proximal neck taper, 125-degree neck angle, and distal longitudinal splines. Manufactured from Tivanium alloy with circumferential, commercially-pure titanium fiber metal pads for biological fixation. Implanted by orthopedic surgeons in clinical/OR settings to replace diseased or damaged hip joints. Provides structural support and biological fixation to restore hip function and alleviate pain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cementless, modular femoral stem; Tivanium alloy substrate; circumferential commercially-pure titanium fiber metal pads for porous coating; 12/14 Morse-type proximal neck taper; 125-degree neck angle; distal longitudinal splines; trapezoidal geometry.

Indications for Use

Indicated for patients requiring total or hemi-hip replacement due to severe hip pain, disability from arthritis (rheumatoid, osteoarthritis, traumatic, polyarthritis), collagen disorders, avascular necrosis, femoral fractures (nonunion, acute, subcapital, comminuted, pathological), congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, previous fusion, or failed prior endoprostheses. 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 Beaded MidCoat Low Head Center Hip Prosthesis (K042776)

Submission Summary (Full Text)

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Special 510(k): Device Modification

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K0617-8Ca

Summary of Safety and Effectiveness

7/24/06

Submitter:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate Device:

Device Description:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Patricia Jenks Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone]

June 23, 2006

VerSys® Fiber Metal MidCoat Low Head Center Hip Prosthesis

Total Hip Prosthesis

Prosthesis, Hip, Semi-Constrained, Metal/Polymer Porous, Uncemented

## 21 CFR § 888.3358

VerSys Beaded MidCoat Low Head Center Hip Prosthesis, manufactured by Zimmer, K042776, cleared November 4, 2004

Like its predicate, the VerSys Fiber Metal MidCoat Low Head Center Hip Prosthesis is a cementless, straight, modular femoral stem. The proposed and predicate devices are designed with trapezoidal geometry and feature 12/14 Morse-type proximal neck tapers to mate with the corresponding 12/14 bore of a femoral head component. Both devices feature 125-degree neck angles and distal, longitudinal splines. The modified device is manufactured from Tivanium Alloy and has circumferential, commercially-pure titanium fiber

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Image /page/1/Picture/1 description: The image shows the Zimmer logo. The logo consists of a large, stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a sans-serif font. The "Z" in the circle is black, and the word "zimmer" is also black.

## Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

metal pads for biological fixation.

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.

The modifications to the VerSys Fiber Metal MidCoat Low Head Center Hip Prosthesis change neither the intended use nor the fundamental scientific technology of the device as compared to the predicate. The modified and unmodified device use the same materials and processes for packaging and sterilization.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a curved line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. c/o Patricia Jenks Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

JUL 2 4 2006

Re: K061786

Trade/Device Name: VerSys® Fiber Metal MidCoat Low Head Center 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: June 23, 2006 Received: June 26, 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,

Boutara Buekum

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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## K061786

## Indications for Use

510(k) Number (if known):

Devicé Name:

VerSys® Fiber Metal MidCoat Low Head Center Hip Prosthesis

Indications for Use:

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, 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.

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)
(hithie Guchand

(Division Sign-Of Division of General, Restorative, and Neurological Besters

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510(k) Number K111786