VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS

K964769 · Zimmer, Inc. · LPH · Feb 13, 1997 · Orthopedic

Device Facts

• Record ID: K964769
• Device Name: VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following: Total Hip Replacement: 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: 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

Modular femoral hip prosthesis; collarless stem; Tivanium (Ti-6Al-4V) alloy construction. Designed for cementless fixation via proximal circumferential fiber metal pad (commercially pure titanium) for bone ingrowth and roughened midstem for bone ongrowth. Features Morse-type 12/14 proximal neck taper for femoral head attachment. Trapezoidal proximal body geometry optimizes metaphyseal fill and rotational stability. Distal shaft tapered in medial/lateral and anterior/posterior planes to encourage proximal fixation. Available in nine sizes with standard/large metaphysis options. Used by orthopedic surgeons in clinical settings for total or hemi-hip arthroplasty. Restores joint geometry and kinematics; provides biological fixation to bone.

Clinical Evidence

No clinical data provided for this specific device. Relies on literature reporting satisfactory results for porous-coated, cementless hip prostheses generally.

Technological Characteristics

Material: Tivanium (Ti-6Al-4V) alloy stem; commercially pure titanium fiber metal pad. Design: Collarless, modular, trapezoidal proximal body, tapered distal shaft. Fixation: Cementless, porous-coated (proximal) and roughened (midstem) for bone ingrowth/ongrowth. Connection: Morse-type 12/14 proximal neck taper. Sizes: 10-18 mm. Sterilization: Not specified.

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, nonunion of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, failed previous endoprostheses, or acute femoral neck fractures. Hemi-hip replacement indicated for elderly/debilitated patients, fracture dislocations, irreducible fractures, or high subcapital/comminuted femoral neck fractures.

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

• Astel F-24 Femoral Hip Prosthesis (K901687)
• MultiLock® Hip Prosthesis (K921308)
• Zimmer® Anatomic Hip Prosthesis (K922071)
• Delta Hip Prosthesis (K961378)

Submission Summary (Full Text)

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PO. Box 708
Warsaw, IN 46581-0708
219 267-6131

FEB 13 1997

Summary of Safety and Effectiveness
VerSys™ Hip System--Fiber Metal
Taper Hip Prosthesis

- Submitted By:
Zimmer, Inc.
P.O. Box 708
Warsaw, Indiana 46581-0708
219-267-6131

- Contact Person:
Karen Cain
Regulatory Affairs Specialist
Telephone: [phone]
Fax: [phone]

- Date:
November 22, 1996

- Trade Name: VerSys™ Hip System--Fiber Metal Taper Hip Prosthesis

- Common Name: Femoral Hip Prosthesis

- Classification Name: Hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis

- Predicate Devices for the Femoral Stem:
- Astel F-24 Femoral Hip Prosthesis, manufactured by Zimmer, K901687, cleared September 7, 1990
- MultiLock® Hip Prosthesis, K921308, cleared February 22, 1994
- Zimmer® Anatomic Hip Prosthesis, K922071, cleared February 22, 1994
- Delta Hip Prosthesis, K961378, cleared October 8, 1996

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A Bristol-Myers Squibb Company

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- Device Description

The Fiber Metal Taper Hip Prosthesis is a collarless, modular femoral stem manufactured from *Tivanium® Ti-6Al-4V Alloy*. *Tivanium Alloy* is a high fatigue strength material with a long history of successful clinical use and exceptional biocompatibility. The Fiber Metal Taper Hip Prosthesis is primarily designed for use in patients with a champagne flute (trumpet) type femur but may be used in other patients based upon the surgeon’s judgment.

The modular connection of the femoral stem is a Morse-type 12/14 proximal neck taper designed to mate with the corresponding 12/14 bore of a femoral head component. The neck of the prosthesis increments progressively in offset and length with increasing stem size. Progressive offsets and neck lengths are designed to provide restoration of natural joint geometry and kinematics.

The proximal body of the stem features a trapezoidal geometry which optimizes metaphyseal fill of the proximal femur and provides rotational stability. The Fiber Metal Taper Hip Prosthesis will be available in nine sizes (10 through 18) with size increments of 1 mm. Stem sizes 12 through 16 mm are designed with two proximal body options, standard and large metaphysis, to accommodate variations in patient anatomy.

A commercially pure titanium circumferential fiber metal pad is metallurgically bonded to the proximal one-third of the stem. The purpose of the fiber metal pad is to achieve biological fixation to bone without the use of bone cement. The surface of the midstem region features a roughened surface providing for bone ongrowth and implant fixation. The distal shaft is tapered in both the medial/lateral plane and the anterior/posterior plane to encourage proximal fixation and minimize distal stem engagement in the canal.

- Intended Use

The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following:

- Total Hip Replacement:

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

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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:**

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.

- **Comparison to Predicate Devices**

All hip systems listed above are substantially equivalent to each other and the Fiber Metal Taper Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. All predicate devices feature a porous or roughened surface and are modular in design. Each has a Morse-type proximal neck taper that mates with a femoral head which, in turn, articulates upon the ultra-high molecular-weight polyethylene (UHMWPE) bearing surface of a total hip or hemi-hip acetabular component. All predicate devices and the Fiber Metal Taper Hip Prosthesis are manufactured from metal alloys that have a history of successful clinical use in orthopaedic applications.

- **Clinical Data**

One current method of hip prosthesis implantation relies upon mechanical fixation through initial implant stabilization with secondary fixation supplied by bone ingrowth or bone ongrowth. The Fiber Metal Taper Hip Prosthesis is an example of a device designed to achieve biologic fixation to bone through bone ingrowth and bone ongrowth. Many studies published in the literature report satisfactory results are obtained through the use of porous coated, cementless hip prostheses.

RA11601K.510

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