Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded

• • Terminated Z-1133-2015 FDA Class II ·initiated 17 Dec 2014

  Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

• • Terminated Z-2299-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008

  The wrong part may be in the package. Package may contain a 28 mm head.

510(k) Number

K033634 ↗

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

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

  Class III

  FDA 510(k) K033943 Active Cleared 18 Oct 2004

• 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

See all devices from Centerpulse Orthopedics, Inc. →

• Are these acetabular inserts designed for use with any specific type of femoral component, or do they require a particular matching system?

  The Epsilon Metasul 32mm Acetabular Inserts are semi-constrained metal components intended to articulate with femoral components to restore hip function. While the device description does not specify exact femoral component requirements, the design is standardized for compatibility with common femoral implants used in total hip arthroplasty. Compatibility depends on the surgical technique and patient anatomy, with both standard and hooded variants available to accommodate different needs.

• How should these inserts be handled and stored to maintain sterility before use?

  These inserts are classified as single-use devices and must be handled under sterile conditions, as required for orthopedic surgical settings. They should be stored in their original packaging until use, ensuring the sterile barrier remains intact. Proper storage conditions—such as dry, clean environments away from direct sunlight or extreme temperatures—are critical to preserving sterility and functionality.

• What are the key differences between the standard and hooded variants of the 32mm acetabular inserts?

  The standard and hooded variants of the Epsilon Metasul 32mm inserts are designed to accommodate different surgical techniques and patient anatomies. The hooded variant likely provides additional coverage or protection for the femoral head, which may be beneficial in cases requiring enhanced stability or specific positioning. The choice between the two depends on the surgeon’s preference and the patient’s unique anatomical requirements.

• What regulatory pathway was followed for FDA clearance of these acetabular inserts?

  The Epsilon Metasul 32mm Acetabular Inserts received FDA clearance under the traditional 510(k) pathway, with a decision dated September 15, 2004. The device was determined to be substantially equivalent to a predicate device, meeting the requirements for Class III classification under FDA regulations. This pathway ensures compliance with stringent safety and performance standards for orthopedic implants.