Uhmwpe Components-Change in Packaging

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K940743 ↗

FDA Product Code

KWY

Device Class

Class II

Regulation

21 CFR Part 888.3390

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 are UHMWPE Components used for in orthopedic procedures?

  UHMWPE Components are orthopedic devices made of ultra-high molecular weight polyethylene that serve as bearing surfaces in prosthetic joints during joint replacement surgeries, providing durability and low friction movement.

• How are these UHMWPE Components supplied and can they be reused?

  The device is supplied in a change of packaging format and is intended for single-use only. It should not be reused as it is designed for one-time use in surgical procedures.

• What storage conditions are required for these UHMWPE Components?

  The UHMWPE Components require proper storage conditions to maintain their integrity, though specific storage details are not provided in the device information.

• What regulatory status do these UHMWPE Components have?

  The device received FDA 510(k) clearance with product code KWY, classified as substantially equivalent to predicate devices in the orthopedic category.