22 MM COCR HEAD & POLYETHLENE LINER

K960180 · Stelkast Company · LPH · May 2, 1996 · Orthopedic

Device Facts

• Record ID: K960180
• Device Name: 22 MM COCR HEAD & POLYETHLENE LINER
• Applicant: Stelkast Company
• Product Code: LPH · Orthopedic
• Decision Date: May 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 22 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application. A smaller CoCr head with appropriate liner was manufactured to increase polyethylene minimal thickness in the smaller diameter acetabular cups. These components will supplement 28 mm CoCr heads and liners already released in the ProForm and Provident Hip Systems. Only certain neck lengths are available in the 22 mm head in order to provide adequate support.

Device Story

22 mm CoCr femoral head and hooded UHMWPE acetabular liner; components of ProForm and Provident Hip Systems; designed to increase polyethylene thickness in smaller acetabular cups; supplements existing 28 mm head/liner offerings; limited neck lengths available for structural support; used by orthopedic surgeons in hip replacement procedures; provides articulation surface for hip arthroplasty.

Clinical Evidence

Bench testing only; fatigue testing of stem and head satisfied under previous 510(k) submissions; liner testing satisfied under previous submissions.

Technological Characteristics

Materials: Co-Cr-Mo alloy and UHMWPE. Components: 22 mm CoCr head, hooded acetabular liner. Design: Modified internal diameter to increase polyethylene thickness in smaller acetabular cups. Limited neck lengths for structural support.

Indications for Use

Indicated for patients requiring hip arthroplasty, specifically those needing smaller diameter acetabular cups where increased polyethylene thickness is required.

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.

Reference Devices

• ProForm Hip System
• Provident Hip System

Submission Summary (Full Text)

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StelKast Incorporated

K 960180

MAY - 2 1996

January 10, 1996

# 22 MM CAST CoCr HEAD AND POLYETHYLENE ACETABULAR SHELL LINER

## Summary of Safety and Effectiveness Information Upon Which The Substantial Equivalence Determination is Based [510(k) Summary]

The 22 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.

Fatigue testing of the stem and 22 mm head was satisfied under previously released 510(k) submissions. Likewise, the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed.

A smaller CoCr head with appropriate liner was manufactured to increase polyethylene minimal thickness in the smaller diameter acetabular cups. These components will supplement 28 mm CoCr heads and liners already released in the ProForm and Provident Hip Systems. Only certain neck lengths are available in the 22 mm head in order to provide adequate support.

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