Omnifit Threaded Acetabular Components 2005 Series

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

510(k) Number

K851404 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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 types of surgical procedures is the Omnifit Threaded Acetabular Components 2005 Series designed for?

  The Omnifit Threaded Acetabular Components 2005 Series is specifically designed for use in total hip arthroplasty (replacement surgery). It serves as an uncemented, semi-constrained acetabular prosthesis, providing a stable fixation interface within the pelvic acetabulum to support load-bearing and articulation with femoral components.

• Are the Omnifit Threaded Acetabular Components 2005 Series reusable or intended for single-use?

  The Omnifit Threaded Acetabular Components 2005 Series are intended for single-use only. They are supplied sterile, adhering to standard sterile medical device protocols to ensure patient safety and infection control.

• How many sizes and models are available in the Omnifit Threaded Acetabular Components 2005 Series, and what does this mean for compatibility?

  The series includes multiple reference codes and sizes, as indicated by the listed FEI numbers (e.g., 3020282716, 3007923096, etc.), ensuring compatibility with a wide range of anatomical requirements and surgical approaches. This variety allows surgeons to select the appropriate size for individual patient needs.

• What regulatory pathway was followed for FDA clearance of the Omnifit Threaded Acetabular Components 2005 Series?

  The Omnifit Threaded Acetabular Components 2005 Series received FDA 510(k) clearance through the traditional review pathway, with a decision of *substantially equivalent* (SESE) to a predicate device. The clearance was granted under the Orthopedic (OR) advisory committee and classified as a Class III medical device, reflecting its critical role in orthopedic surgery.

• How should the Omnifit Threaded Acetabular Components 2005 Series be stored to maintain sterility?

  Since the components are supplied sterile, storage must follow sterile medical device protocols to preserve integrity. This includes keeping them in their original packaging, away from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions.