CONSENSUS APEX DOME HOLE PLUG

K960340 · U.S. Medical Products, Inc. · JDI · Mar 15, 1996 · Orthopedic

Device Facts

• Record ID: K960340
• Device Name: CONSENSUS APEX DOME HOLE PLUG
• Applicant: U.S. Medical Products, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Mar 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CONSENSUS® Apex Dome Hole Plug (PMMA) 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® Apex Dome Hole Plug (PMMA) functions as optional plug for acetabular shell dome apex hole; used as accessory to Consensus® Total Hip System; single-use; sterile; implanted by orthopedic surgeon during hip arthroplasty; prevents cement migration or debris ingress through acetabular shell hole; improves clinical outcomes by maintaining integrity of acetabular construct.

Clinical Evidence

No clinical data provided; device relies on non-clinical performance data and substantial equivalence to predicate.

Technological Characteristics

Material: Polymethylmethacrylate (PMMA) per ASTM F451. Form factor: Single-size plug for acetabular shell dome apex hole. Sterilization: Provided sterile.

Indications for Use

Indicated for patients requiring primary hip intervention or revision due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, avascular necrosis, femoral neck fractures, or fracture-dislocation of the hip, provided 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

• Consensus® Acetabular Cement Pods (K922561)

Submission Summary (Full Text)

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K960340

# ATTACHMENT 8

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

US MEDICAL PRODUCTS, INC.
CONSENSUS® Apex Dome Hole Plug (PMMA)

MAR 15 1996

| 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® Apex Dome Hole Plug

**Common Name:** Hip replacement prosthesis, Acetabular Shell Apex Dome Hole Plug (PMMA)

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

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

**Substantial Equivalence:** equivalent Apex Dome Hole Plug (PMMA) components are as follows:

**Consensus® Acetabular Cement Pods** K922561 SE 07/21/93

**Device Description:** The Consensus® Apex Dome Hole Plug (PMMA) is intended for use with the Consensus® Total Hip System as an addition to the metal acetabular shell and UHMWPE acetabular insert components in the Consensus® Total Hip System. It is a single use device. The Consensus® Apex Dome Hole Plug (PMMA) is designed for use with size compatible Consensus® Total Hip System components:

| Porous coated Acetabular Shell | K922561 | SE 07/21/93 |
| --- | --- | --- |
| Nonporous Acetabular Shell | K922561 | SE 07/21/93 |
| Acetabular Insert, UHMWPE | K922561 | SE 07/21/93 |

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The Concensus® Apex Dome Hole Plug (PMMA) will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.

## Intended Use:

The CONSENSUS® Apex Dome Hole Plug (PMMA) 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® Apex Dome Hole Plug (PMMA), is designed function as an optional plug for the acetabular shell dome apex hole. The Consensus® Apex Dome Hole Plug (PMMA), will be provided sterile and will be available in one size. The material will be polymethylmethacrylate (PMMA), ASTM F451.

## Performance Data:

The Consensus® Apex Dome Hole Plug (PMMA), device performs with substantial equivalence to predicate devices.

## Clinical Data:

None Required

## Conclusions from Non-clinical and Clinical Data:

The Consensus® Apex Dome Hole Plug (PMMA), is substantially equivalent to predicate devices.

## Other Necessary Information:

None Required