← Product Code [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB) · K962564

# RICHARDS TOTAL/PARTIAL PROSTHESIS (K962564)

_Gyrus Ent LLC · ETB · Jan 22, 1997 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K962564

## Device Facts

- **Applicant:** Gyrus Ent LLC
- **Product Code:** [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB.md)
- **Decision Date:** Jan 22, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3450
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Intended Use

The Richards Total/Partial Prosthesis is indicated for the total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect.

## Device Story

Prosthesis for middle ear ossicular chain reconstruction; replaces non-functional ossicles. Device features trimmable shaft and tiltable head for angulation against tympanic membrane. Used by ENT surgeons in clinical settings. Head composed of Hydroxylapatite; shaft composed of Plasti-Pore. Provides structural replacement to restore sound conduction.

## Clinical Evidence

No clinical data provided; substantial equivalence based on design similarity and established material properties of Hydroxylapatite.

## Technological Characteristics

Materials: Hydroxylapatite (head), Plasti-Pore (shaft). Design: Trimmable shaft, tiltable head for angulation. Classification: Total Ossicular Replacement Prosthesis (21 CFR 874.3450) and Partial Ossicular Replacement Prosthesis (21 CFR 874.3495).

## Regulatory Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

## Predicate Devices

- Tilt-Top TORP and PORP (Smith & Nephew ENT)

## Submission Summary (Full Text)

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JAN 22 1997

Food and Drug Administration

510(k) Notification - Richards Total/Partial Prosthesis

June 28, 1996

Smith & Nephew ENT

Smith & Nephew Richards Inc.

2925 Appling Rd., Bartlett, TN 38133

Telephone: 901-373-0200

Toll Free: 800-262-3540

Fax: 901-373-0220

k962564

Smith & Nephew

# 510(k) Summary of Safety and Effectiveness

Trade Name: Richards Total/Partial Prosthesis

Common Name: Partial Ossicular Replacement Prosthesis

Classification Name: Total Ossicular Replacement Prosthesis (§ 874.3450)

Total Ossicular Replacement Prosthesis (§ 874.3495)

Official Contact: Ronald K. Smith

Senior Regulatory Affairs Specialist

Smith & Nephew ENT

a division of Smith & Nephew Richards, Inc.

2925 Appling Road

Bartlett, TN 38133

Telephone: (901) 373-0200

Telefax: (901) 373-0276

Date Prepared: June 28, 1996

The Richards Total/Partial Prosthesis is substantially equivalent to the Tilt-Top TORP and PORP marketed by Smith & Nephew ENT. These devices have the same indications for use, total/partial reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect. The Richards Total/Partial Prosthesis and the predicate devices both have trimmable shafts made of Plasti-Pore and heads that may be tilted for proper angulation against the tympanic membrane. The head of the Richards Total/Partial Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction.

Differences between the Richards Total/Partial Prosthesis and the predicate device should not affect the safety or effectiveness.

RS059601

RI

RICHARDS

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K962564](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K962564)

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