Richards Torp Replacement Ossicular Prosthesis, Total

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Richards Torp

510(k) Number

K952549 ↗

FDA Product Code

ETA

Device Class

Class II

Regulation

21 CFR Part 874.3495

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Hydrocell Nasal and Sinus Packs

  Class I

  FDA 510(k) K954491 Active Cleared 15 Nov 1995

• Black Oval-Top Torp/Porp

  Class II

  FDA 510(k) K934107 Active Cleared 8 Jun 1994

• Profix Conforming Plus Tibial Insert

  Class II

  FDA 510(k) K946236 Active Cleared 6 Jul 1995

• Epistaxis Nasal Balloon Catheter

  Class I

  FDA 510(k) K921199 Active Cleared 8 Jul 1992

• Geri Total Hip System

  Class II

  FDA 510(k) K905186 Active Cleared 15 Feb 1991

• Rihards Titanium Half Pin

  Class II

  FDA 510(k) K920024 Active Cleared 21 Jan 1992

See all devices from Smith & Nephew Richards, Inc. →

• What is the Richards Torp used for?

  The Richards Torp is an ossicular prosthesis intended to replace damaged ossicles in the middle ear, restoring conductive hearing in patients with conditions like otosclerosis or ossicular chain disruption. By mimicking the natural function of the ossicular chain, it facilitates sound transmission from the tympanic membrane to the inner ear, improving auditory performance in individuals with conductive hearing loss.

• Is the Richards Torp sterile and single-use?

  Yes, the Richards Torp is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for optimal performance during surgery.

• What are the key specifications of the Richards Torp?

  The Richards Torp is classified as a Class II medical device under FDA regulations (874.3495) and holds an FDA 510(k) clearance (K952549) with a Substantially Equivalent determination. It is designed specifically for otolaryngology procedures, particularly in Ear, Nose, and Throat (ENT) surgeries, and is manufactured by Smith & Nephew Richards, Inc.

• Are there any special storage instructions for the Richards Torp?

  The provided data does not specify storage conditions for the Richards Torp. Clinicians should follow standard sterile medical device storage guidelines until further information is available.

• Can the Richards Torp be used in MRI procedures?

  No MRI safety information is provided for the Richards Torp. Clinicians should avoid using it in MRI environments unless explicit safety data confirms compatibility, as the device’s material properties or components may not be MRI-safe.