← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K970501

# PEGGED ACETABULAR COMPONENT (K970501)

_Biomet, Inc. · LPH · Apr 30, 1997 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K970501

## Device Facts

- **Applicant:** Biomet, Inc.
- **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md)
- **Decision Date:** Apr 30, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3358
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.

## Device Story

Pegged Acetabular Component; hemispherical metallic shell; three superior pegs/spikes for initial fixation and rotational control; porous-coated outer surface. Used with Biomet Ringloc Acetabular Liners and any commercially available femoral component. Implanted by orthopedic surgeons in clinical settings for hip joint reconstruction. Provides mechanical stability and joint articulation; benefits patients by restoring hip function damaged by disease or trauma.

## Clinical Evidence

No clinical data provided; substantial equivalence based on design and functional similarity to predicate devices.

## Technological Characteristics

Hemispherical metallic shell; three superior fixation pegs; porous-coated outer surface. Designed for use with Ringloc Acetabular Liners and standard femoral components. Single-use implant.

## Regulatory 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.

## Predicate Devices

- Universal® Acetabular Component (Biomet)
- Mallory-Head® Acetabular Component (Biomet)
- Reflection™ Porous-Coated Acetabular Component (Richards)
- PCA® Acetabular Component (Howmedica)
- Duraloc™ 300 Acetabular Cup System (DePuy)

## Submission Summary (Full Text)

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BIOMET

K970501

APR 30 1997

# Summary of Safety and Effectiveness

Sponsor: Biomet, Inc.
Airport Industrial Park
Warsaw, Indiana 46580

Device Name: Pegged Acetabular Component

Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (888.3358) and Hip joint metal/polymer semi-constrained cemented prosthesis (888.3350)

Device Description: The Pegged Acetabular Component is a full hemispherical metallic shell. The shell has three superiorly places pegs or spikes to provide initial fixation and rotational control. The outer surface of the shell is porous coated. The device is to be used in conjunction with Biomet's Ringloc Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.

Intended Use: The Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

|  Reaction to the bone cement | Blood vessel damage | Bone fracture  |
| --- | --- | --- |
|  Deformity of the joint | Soft tissue imbalance | Infection  |
|  Cardiovascular disorders | Delayed wound healing | Hematoma  |
|  Fracture of the cement | Metal sensitivity | Dislocation  |
|  Implant loosening/migration | Fracture of component | Excessive wear  |
|  Breakdown of porous surface | Tissue growth failure | Nerve damage  |

Substantial Equivalence: The Pegged Acetabular Component is substantially equivalent to almost all acetabular devices on the market in overall design and intended function. Predicate devices include:

- Universal® Acetabular Component (Biomet)
- Mallory-Head® Acetabular Component (Biomet)
- Reflection™ Porous-Coated Acetabular Component (Richards)
- PCA® Acetabular Component (Howmedica)
- Duraloc™ 300 Acetabular Cup System (DePuy)

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K970501](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K970501)

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