Prosthesis, Richards Mod II Knee

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760245 ↗

FDA Product Code

HRY

Device Class

Class II

Regulation

21 CFR Part 888.3530

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Plug-Lok Cement Restirctor

  Class II

  FDA 510(k) K791125 Active Cleared 27 Jun 1979

• Spectron Primary Stem Femoral Prosthes

  Class II

  FDA 510(k) K823727 Active Cleared 8 Mar 1983

• Reuter Bobbin Ventila. Tube-Titanium

  Class II

  FDA 510(k) K820362 Active Cleared 2 Mar 1982

• Pullen Plastic-Pore Plugs

  Class II

  FDA 510(k) K772066 Active Cleared 20 Dec 1977

• Spoon-Bobbin Drain Tube W/ Wire, Otology

  Class II

  FDA 510(k) K760438 Active Cleared 21 Sep 1976

• Colles Fracture Frame

  Class II

  FDA 510(k) K830154 Active Cleared 2 Feb 1983

See all devices from Richard'S Medical Equip., Inc. →

• What is the PROSTHESIS, RICHARDS MOD II KNEE used for?

  This device is a knee joint replacement implant designed to articulate the femur and tibia during orthopedic surgical procedures. It replaces the damaged femorotibial joint surface to restore knee function in patients requiring total knee arthroplasty.

• How is the PROSTHESIS, RICHARDS MOD II KNEE supplied and is it reusable?

  The implant is supplied as a sterile, single-use device intended for one-time implantation during surgery. It is not designed for cleaning, resterilization, or reuse due to risks of material degradation, contamination, and compromised structural integrity after initial use.

• What materials and design features define the PROSTHESIS, RICHARDS MOD II KNEE?

  It is a semi-constrained, cemented femorotibial prosthesis made of metal and polymer components. The semi-constrained design provides moderate stability while allowing some natural knee motion, and it requires bone cement for fixation to the femur and tibia.

• What regulatory pathway was used for the PROSTHESIS, RICHARDS MOD II KNEE?

  The device received FDA 510(k) clearance under number K760245, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II medical device under regulation 888.3530 for knee joint prostheses.