← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K960340

# CONSENSUS APEX DOME HOLE PLUG (K960340)

_U.S. Medical Products, Inc. · JDI · Mar 15, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K960340

## Device Facts

- **Applicant:** U.S. Medical Products, Inc.
- **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md)
- **Decision Date:** Mar 15, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3350
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **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.

## Regulatory 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](/device/K922561.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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 (512) 257-4835
Fax (512) 257-8300
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

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K960340](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K960340)

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