Who is the manufacturer of RICHARDS TOTAL/PARTIAL PROSTHESIS?

Gyrus Ent LLC filed the 510(k) submission for RICHARDS TOTAL/PARTIAL PROSTHESIS (K962564).

What is the FDA product code for RICHARDS TOTAL/PARTIAL PROSTHESIS?

ETB. It is classified under 21 CFR 874.3450 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for RICHARDS TOTAL/PARTIAL PROSTHESIS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RICHARDS TOTAL/PARTIAL PROSTHESIS?

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

Who can help prepare an FDA 510(k) submission like RICHARDS TOTAL/PARTIAL PROSTHESIS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RICHARDS TOTAL/PARTIAL PROSTHESIS

K962564 · Gyrus Ent LLC · ETB · Jan 22, 1997 · Ear, Nose, Throat

Device Facts

Record ID	K962564
Device Name	RICHARDS TOTAL/PARTIAL PROSTHESIS
Applicant	Gyrus Ent LLC
Product Code	ETB · Ear, Nose, Throat
Decision Date	Jan 22, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3450
Device Class	Class 2
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).

Indications for Use

Indicated for patients requiring total or partial ossicular chain reconstruction due to disease, trauma, or congenital defects affecting middle ear function.

Regulatory Classification

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)

Related Devices

K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES · Grace Medical, Inc. · Jun 28, 2006
K993234 — MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS · Micromedics, Inc. · Nov 10, 1999
K091187 — GRACE DYNAMIC TORP · Grace Medical, Inc. · Sep 14, 2009
K945105 — POLY/PLATINUM WIRE PISTON · Micromed Development Corp. · May 14, 1996
K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM · Invotec International, Inc. · Mar 3, 2003

Submission Summary (Full Text)

{0} 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