Inter-Op Metasul Hooded and Protrusio Acetabular Inserts

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

510(k) Number

K001536 ↗

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 acetabular deformities are these inserts specifically designed to address in hip replacement surgery?

  These inserts are specifically designed to address protrusio acetabuli, a condition where the acetabulum (hip socket) becomes abnormally shallow or deformed, causing the femoral head to protrude into the pelvis. The hooded design provides structural support and improved fit, helping to restore proper acetabular geometry during hip replacement procedures.

• Are these inserts reusable or intended for single-use, and how are they supplied?

  The Inter-Op Metasul Hooded and Protrusio Acetabular Inserts are intended for single-use only and are supplied sterile to ensure patient safety. They are not designed for reuse, aligning with standard orthopedic implant practices to prevent cross-contamination and maintain sterility.

• What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians?

  These inserts received FDA 510(k) clearance (K001536) under the Traditional 510(k) Review pathway, with a decision date of July 27, 2000. The clearance was granted as substantially equivalent to a predicate device, meaning the FDA determined they have the same intended use and technological characteristics as a previously approved product. Clinicians can rely on this classification, as it indicates the device meets FDA standards for safety and effectiveness in its specified orthopedic application.

• How many different sizes or models of these inserts are available, and are they all compatible with the same surgical approach?

  The device data lists multiple registration numbers (e.g., 3020282716, 3007923096, etc.), which correspond to distinct sizes and models of the Inter-Op Metasul Hooded and Protrusio Acetabular Inserts. While the exact dimensions aren’t specified, the variety suggests they are designed to accommodate different patient anatomies and acetabular deformities. All models are semi-constrained, metal, and uncemented, ensuring compatibility with standard orthopedic surgical techniques for acetabular reconstruction.