Allofit Acetabular System

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

510(k) Number

K003758 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Natural-Hip Cocr Offset Stem

  Class II

  FDA 510(k) K973681 Active Cleared 19 Dec 1997

• Sulzer Orthopedics Converge Acetabular System

  Class II

  FDA 510(k) K012961 Active Cleared 18 Oct 2001

• Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

  Class II

  FDA 510(k) K983153 Active Cleared 4 Dec 1998

• Natural-Hip Porous Stem with Offset

  Class II

  FDA 510(k) K973675 Active Cleared 19 Dec 1997

• Allofit Acetabular System 32mm Alpha Durasul Inserts

  Class II

  FDA 510(k) K013935 Active Cleared 13 Dec 2001

• Magna-Rom 21 Knee Systeem

  Class II

  FDA 510(k) K991143 Active Cleared 11 Jun 1999

See all devices from Sulzer Orthopedics, Inc. →

• What types of hip procedures is the Allofit Acetabular System designed for, and why is it considered semi-constrained?

  The Allofit Acetabular System is specifically designed for total hip arthroplasty (replacement) procedures, where it replaces the natural acetabulum to provide structural support and articulation with the femoral head. It is classified as semi-constrained because its design allows for some rotational freedom of the femoral head while still maintaining stability, reducing the risk of dislocation compared to fully constrained implants. This balance is critical for patients who require durable fixation without sacrificing mobility.

• How many component sizes or variants are available for the Allofit Acetabular System, and how does this variety benefit surgeons?

  The Allofit Acetabular System includes multiple component sizes and variants, as indicated by the listed FEI numbers (e.g., 3020282716, 3007923096, etc.). This extensive range allows surgeons to select the most appropriate acetabular component for each patient’s anatomy, ensuring a precise fit, optimal coverage, and improved stability during total hip replacement. Customization reduces the risk of complications like impingement or loosening.

• Is the Allofit Acetabular System intended for single-use or can it be reused in multiple procedures?

  The Allofit Acetabular System is explicitly described as a reusable surgical implant, meaning it is engineered for sterilization and repeated use in orthopedic settings. This design aligns with the need for cost-effective, high-quality implants in clinical environments where sterility protocols are strictly followed. Reusability also supports sustainability by reducing medical waste.

• What regulatory pathway was followed for the FDA clearance of the Allofit Acetabular System, and what does this mean for its use in clinical settings?

  The Allofit Acetabular System received FDA clearance through a 510(k) Traditional pathway, with a decision code of SESE (Substantially Equivalent) under the Orthopedic (OR) Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness. Clinically, this clearance confirms the system’s compliance with regulatory requirements for use in total hip arthroplasty procedures, though surgeons must still follow manufacturer instructions and local protocols.

• How should the Allofit Acetabular System be stored to maintain its integrity before use?

  While the provided data does not specify storage conditions explicitly, as a reusable metal-based implant intended for sterile use in orthopedic surgery, the Allofit Acetabular System should be stored in a clean, dry environment protected from contamination, moisture, and physical damage. Proper packaging and adherence to manufacturer guidelines for sterilization (e.g., autoclave or ethylene oxide) are essential to preserve its structural integrity and ensure sterility before surgical use.