Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded

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

510(k) Number

K033943 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate

  Class II

  FDA 510(k) K031183 Active Cleared 14 Jul 2003

• Modification to Alloclassic Zweymuller Sl Offset Femoral Stem

  Class II

  FDA 510(k) K033664 Active Cleared 17 Dec 2003

• Natural-Knee II Unicompartmental Knee System

  Class II

  FDA 510(k) K033810 Active Cleared 5 Mar 2004

• Alloclassic Zweymueller Sl/Sll Femoral Stem

  Class II

  FDA 510(k) K030373 Active Cleared 6 Mar 2003

• Converge Reti-Lock Multi-Hole Reinforcement Cup

  Class II

  FDA 510(k) K032348 Active Cleared 24 Oct 2003

• Durasul Bipolar

  Class II

  FDA 510(k) K040947 Active Cleared 27 Aug 2004

See all devices from Centerpulse Orthopedics, Inc. →

• What are the primary uses of the Alpha Metasul 28mm and 32mm Acetabular Inserts in hip replacement surgery?

  The Alpha Metasul 28mm and 32mm Acetabular Inserts are designed as semi-constrained, uncemented metal components for total hip arthroplasty. They provide a bearing surface to articulate with femoral components, enabling smooth hip joint movement after replacement. These inserts are specifically intended for use in orthopedic procedures where a stable acetabular fit is required.

• Are these inserts available in multiple sizes and configurations, and how do they pair with other components?

  Yes, the Alpha Metasul inserts come in two diameters—28mm and 32mm—and two configurations: standard and hooded. They are engineered to mate with Allofit Acetabular Shells, which range from 48mm to 68mm in 2mm increments for the 28mm inserts and 52mm to 68mm in 2mm increments for the 32mm inserts. This modular design allows for precise customization to fit the patient’s anatomy during surgery.

• How should these acetabular inserts be stored, and is there any information about their sterility or reuse?

  The provided data does not specify storage conditions or sterility requirements for the Alpha Metasul inserts. Additionally, there is no explicit indication in the documentation whether these inserts are intended for single-use or can be reused. It is critical to follow the manufacturer’s guidelines or institutional protocols for storage and handling to ensure proper sterility and functionality.

• What regulatory pathway was followed for the approval of these acetabular inserts, and what classification do they hold?

  The Alpha Metasul 28mm and 32mm Acetabular Inserts are classified as Class III devices under FDA regulations and received 510(k) clearance through a traditional review pathway. The submission was deemed substantially equivalent to a predicate device and was reviewed by the Orthopedic (OR) Advisory Committee. The clearance number is K033943.