ULTIMA FX FEMORAL HIP STEMS

K963885 · Johnson & Johnson Professionals, Inc. · KWY · Dec 9, 1996 · Orthopedic

Device Facts

• Record ID: K963885
• Device Name: ULTIMA FX FEMORAL HIP STEMS
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: KWY · Orthopedic
• Decision Date: Dec 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ULTIMA Fx Femoral Hip Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Device Story

ULTIMA Fx Femoral Hip Stems; cemented and uncemented designs; manufactured from cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. Used in total or partial hip replacement procedures; implanted by orthopedic surgeons in clinical settings. Stems mate with P.F.C. or ULTIMA Unipolar hip heads (10/12 taper). Provides structural support for hip joint; restores joint function; alleviates pain/disability caused by arthritis, fractures, or congenital conditions. Cemented version includes cobra flange; press-fit version designed for uncemented fixation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. Design: Cemented (8-11mm distal diameter, 130-165mm length, 2.0-3.6mm cement mantle, 37-46mm offset, cobra flange) and uncemented/press-fit (10.5-15mm distal diameter, 125-165mm length, 34-46mm offset). Interface: 10/12 taper for hip head attachment.

Indications for Use

Indicated for patients requiring total or partial hip replacement due to severe pain/disability from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion with inadequate bone stock.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• Biomet Hip Fracture System
• Biomet Bi-Metric Hip System – Collarless
• Biomet APF Series Modular APF (Anatomical Press Fit)
• Zimmer VerSys™ Hip System
• Wright McCutchen Hip Stem
• Wright Nexus™ Hip Stem
• Wright Resolution™ Microtextured Femoral Stem
• Howmedica Percision Osteolock™ Hip System
• Osteonics Omnifit® Normalized Stem – Collarless

Submission Summary (Full Text)

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DEC 9 1996

K96 3885

510(k) Summary

September 24, 1996

Johnson & Johnson Professional, Inc.
325 Paramount Drive
Raynham, MA 02767-0350

Contact Person: John Ferros
Phone: [phone]

# Name of Device

Classification Name: Hip Joint Femoral Metal/Polymer Semi-Constrained Prosthesis Class II per 21 CFR § 888.3390. This falls under the Orthopaedics panel/87.

Common Name: Hip Prosthesis.

Trade Name/Proprietary Name: ULTIMA® Fx Femoral Hip Stems

Performance Standards: No performance standards have been developed for this device.

# Predicate Devices

| Biomet Hip Fracture System |
| --- |
| Biomet Bi-Metric Hip System – Collarless |
| Biomet APF Series Modular APF (Anatomical Press Fit) |
| Zimmer VerSys™ Hip System |
| Wright McCutchen Hip Stem |
| Wright Nexus™ Hip Stem |
| Wright Resolution™ Microtextured Femoral Stem |
| Howmedica Percision Osteolock™ Hip System |
| Osteonics Omnifit® Normalized Stem – Collarless |

# Description of Device

The ULTIMA Fx Femoral Hip Stems will be offered in both a cemented design and uncemented design, both manufactured of cobalt-chromium-molybdenum alloy (Co-Cr-Mo). The stems will be offered with the following features:

| Feature | ULTIMA Fx Cemented Stem | ULTIMA Fx Press-Fit Stem |
| --- | --- | --- |
| Distal Diameter | 8 - 11 mm | 10.5 - 15 mm |
| Length | 130 - 165mm | 125 - 165 mm |
| Cement Mantle | 2.0 - 3.6 mm | N/A |
| Offset | 37 - 46 mm | 34 - 46 mm |
| Cobra Flange | Yes | No |

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The ULTIMA Fx Femoral Hip Stems can be used in either the right or left hip, and are designed to mate with the following hip heads.

| P.F.C.* Hip Heads (10/12 Taper) |
| --- |
| ULTIMA* Unipolar Hip Heads (10/12 Taper) |

## Intended Use

The ULTIMA Fx Femoral Hip Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

## Technological Characteristics Compared to Predicate Device

The ULTIMA Fx Femoral Hip Stems are technically equivalent to the predicate devices mentioned above.

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