Tibial Plateu

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K780284 ↗

FDA Product Code

MBV

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Delta Shoulder

  Class II

  FDA 510(k) K021478 Active Cleared 18 Nov 2003

• Synatomic Revision Femoral Prosthesis

  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

  Class II

  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

  Class II

  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

  Class II

  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →

• What is the intended use of the Tibial Plateau prosthesis?

  This device is a semi-constrained knee prosthesis designed for patello-femorotibial applications. It is constructed from a combination of polymer and metal materials to provide structural support within the knee joint.

• How is the Tibial Plateau fixed in place?

  The prosthesis is designed as a cemented device, meaning it is intended to be secured within the knee joint using bone cement during the surgical procedure.

• What is the regulatory status of this device?

  The Tibial Plateau is classified as a Class 2 medical device under regulation number 888.3560. It received FDA 510(k) clearance under K780284, having been determined to be substantially equivalent to existing devices.