CONSENSUS ACETABULAR SHELL, ALL UHMWPE

K960302 · U.S. Medical Products, Inc. · JDI · Apr 1, 1996 · Orthopedic

Device Facts

• Record ID: K960302
• Device Name: CONSENSUS ACETABULAR SHELL, ALL UHMWPE
• Applicant: U.S. Medical Products, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Apr 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CONSENSUS® Acetabular Shell, All UHMWPE is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck. 2. Osteoarthrosis involving femoral and acetabular articular surfaces. 3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures. 4. Fracture-dislocation of the hip. 5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

Device Story

Consensus® Acetabular Shell is a single-use, all-UHMWPE hip replacement component; functions as an alternative to metal-backed acetabular shells within the Consensus® Total Hip System. Device articulates with compatible Consensus® femoral heads (Biolox Ceramic, Zirconia, or CoCrMo). Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Provides a bearing surface for the femoral head to restore hip joint function; benefits patients by addressing arthritis, necrosis, or fracture-related joint failure.

Clinical Evidence

No clinical data provided; substantial equivalence based on non-clinical performance data and design similarity to predicate.

Technological Characteristics

Material: Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM F648. Form factor: Acetabular shell available in multiple sizes for 22mm, 26mm, and 28mm femoral heads. Sterilization: Provided sterile. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring primary hip intervention due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, avascular necrosis, non-union of femoral neck fractures, or fracture-dislocation of the hip; also indicated for revision of unsatisfactory hip components where sufficient bone stock exists.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Howmedica Acetabular Shell, All UHMWPE (K912426)

Reference Devices

• Femoral Head, Biolox Ceramic (K922561)
• Femoral Head, Zirconia (K955386)
• Femoral Head, CoCrMo (K922561)

Submission Summary (Full Text)

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K960302

# ATTACHMENT 8

## Summary of Safety and Effectiveness 510(k) SUMMARY

APR - 1 1996

US MEDICAL PRODUCTS, INC.
CONSENSUS® Acetabular Shell, All UHMWPE

| US Medical Products, Inc.
12201 Technology Blvd.
Suite 100
Austin, Texas 78727 | William N. Thompson, Director
Quality Assurance and Regulatory Affairs
Voice [phone]
Fax [phone]
Date of Preparation: 15 Dec 1995 |
| --- | --- |

**Trade Name:** Consensus® Acetabular Shell, All UHMWPE

**Common Name:** Hip replacement prosthesis, Acetabular Shell, All UHMWPE

**Classification Name:** Class II device, under the following classification:

Prosthesis, Hip, Semi-Constrained Metal/ Polymer classification 21 CFR 888.3350

**Substantial Equivalence:** equivalent Acetabular Shell, All UHMWPE components are as follows:

### Howmedica Acetabular Shell, All UHMWPE K912426 SE 8-21-91

**Device Description:** The Consensus® Acetabular Shell, All UHMWPE is intended for use with the Consensus® Total Hip System as an alternative to the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Acetabular Shell, All UHMWPE is designed for use with size compatible Consensus® Total Hip System components:

| Femoral Head, Biolox Ceramic | K922561 | SE 07-21-93 |
| --- | --- | --- |
| Femoral Head, Zirconia | K955386 | SE 11/06/95 |
| Femoral Head, CoCrMo | K922561 | SE 07-21-93 |

The 22mm diameter, 26mm diameter, and 28mm Shells are intended to be used with compatible diameter femoral head components.

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The Concensus® Acetabular Shell, All UHMWPE will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm in 2mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.

## Intended Use:

The CONSENSUS® Acetabular Shell, All UHMWPE is indicated for use in:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck.
2. Osteoarthrosis involving femoral and acetabular articular surfaces.
3. Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
4. Fracture-dislocation of the hip.
5. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

## Summary of Technological Characteristics:

The Consensus® Acetabular Shell, All UHMWPE, is designed to articulate with the various Consensus® Hip femoral head components. The Consensus® Acetabular Shell, All UHMWPE, will be provided sterile and will be available in fourteen sizes for 22mm heads (42mm to 68mm in 2mm increments), in twelve sizes for 26mm heads (46mm to 68mm in 2mm increments), and in eleven sizes for 28mm heads (48-68mm in 2mm increments). The material will be ultra high molecular weight polyethylene (UHMWPE), ASTM F648.

## Performance Data:

The Consensus® Acetabular Shell, All UHMWPE, device performs with substantial equivalence to predicate devices.

## Clinical Data:

None Required

## Conclusions from Non-clinical and Clinical Data:

The Consensus® Acetabular Shell, All UHMWPE, is substantially equivalent to predicate devices.

## Other Necessary Information:

None Required