Osteonics DRM Acetabular Component

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

510(k) Number

K903636 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →

• What is the Osteonics DRM Acetabular Component used for?

  The Osteonics DRM Acetabular Component is designed for use in hip joint replacement procedures as an orthopedic implant, intended for surgical implantation in orthopedic settings to replace the acetabular side of the hip joint.

• How is the Osteonics DRM Acetabular Component supplied and is it reusable?

  The device is supplied as a single component for surgical implantation; however, the provided data does not specify whether it is sterile, single-use, or reusable, so no determination about reusability can be made from the available information.

• What regulatory pathway was used for the Osteonics DRM Acetabular Component?

  The Osteonics DRM Acetabular Component received FDA clearance through the traditional 510(k) pathway as a substantially equivalent device, with clearance number K903636 granted on October 30, 1990, under product code JDI.