Omnifit Threaded Acetabular Component

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

Full name

(Modified) Omnifit Threaded Acetabular Component

510(k) Number

K861723 ↗

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 hip procedures is the Omnifit Threaded Acetabular Component designed for, and why is it considered semi-constrained?

  The Omnifit Threaded Acetabular Component is designed for total hip arthroplasty procedures where the damaged or diseased acetabulum needs replacement. It is classified as semi-constrained because its design allows for some degree of movement between the acetabular component and the femoral head, while still providing stability to the hip joint. This balance helps ensure proper articulation and load distribution, reducing the risk of dislocation compared to unconstrained designs.

• Is the Omnifit Threaded Acetabular Component reusable or single-use, and how does this affect its clinical use?

  The Omnifit Threaded Acetabular Component is explicitly described as a reusable medical implant, meaning it is intended for multiple surgical uses after proper cleaning, sterilization, and handling as directed by the manufacturer. This makes it cost-effective for repeated procedures but requires strict adherence to sterilization protocols to ensure patient safety and device integrity between uses.

• What size options are available for the Omnifit Threaded Acetabular Component, and how does this accommodate different patients?

  The Omnifit Threaded Acetabular Component comes in multiple sizes to match varying anatomical requirements of patients. The exact range of sizes isn’t specified here, but the availability of diverse options ensures compatibility with different pelvic morphologies, improving fixation stability and reducing the need for custom modifications during surgery.

• How is the Omnifit Threaded Acetabular Component fixed to the pelvis, and what advantages does this threaded design offer?

  The Omnifit Threaded Acetabular Component features a threaded design that allows it to be securely screwed into the pelvic bone, providing primary fixation. This threaded mechanism enhances stability by engaging the bone threads, reducing the risk of loosening over time—a common issue with unthreaded acetabular components. The secure fixation also supports early weight-bearing post-surgery.

• What regulatory pathway was used for FDA clearance of this device, and what does that mean for its clinical use?

  The Omnifit Threaded Acetabular Component received FDA clearance through the 510(k) Traditional pathway, with a determination of substantial equivalence to a predicate device. This means the FDA reviewed it against an existing, legally marketed device and found it to have the same intended use and technological characteristics. Clinically, this clearance indicates the device meets FDA standards for safety and effectiveness, but surgeons should still follow manufacturer guidelines for proper use.