KDG Acetabular Component

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

510(k) Number

K891262 ↗

FDA Product Code

LWJ

Device Class

Class II

Regulation

21 CFR Part 888.3360

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 is the KDG Acetabular Component used for?

  The KDG Acetabular Component is designed specifically for total hip arthroplasty (replacement surgery) to replace the damaged acetabulum. It provides a stable articulation surface for the femoral component, ensuring proper hip joint function. Its uncemented fixation allows for bone integration over time, reducing the need for adhesive materials while maintaining stability during recovery.

• Is the KDG Acetabular Component reusable or single-use?

  The KDG Acetabular Component is supplied as a reusable medical device. This classification aligns with its intended use in controlled surgical environments where sterilization protocols can be strictly followed. Reusability helps reduce waste while maintaining safety when handled according to sterile medical device protocols.

• What materials is the KDG Acetabular Component made from?

  The KDG Acetabular Component is constructed from a metal/polymer combination, which provides a durable yet biocompatible surface for hip joint replacement. The specific materials are chosen to ensure compatibility with the body and to support long-term stability and function in orthopedic applications.

• How is the KDG Acetabular Component sterilized and stored?

  As a reusable device, the KDG Acetabular Component must be sterilized using validated medical device sterilization methods (e.g., autoclave or ethylene oxide) before each use. Storage should follow manufacturer guidelines to prevent contamination, typically in a clean, dry environment with appropriate packaging to maintain sterility until use.

• What regulatory approval does the KDG Acetabular Component hold?

  The KDG Acetabular Component holds FDA 510(k) clearance under the reference number K891262, following a traditional review process. This approval confirms its substantial equivalence to a predicate device and ensures it meets regulatory standards for safety and effectiveness in orthopedic applications.