# K033634: Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Sep 15, 2004 after 301 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883460 (1988). 8 ancestors in all.
76 later devices descend from it; 2 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974728: Inter-OP Metasul Acetabular System, Sulzer Orthopedics, Inc. (1999) Summary page 1.
- K001536: Inter-OP Metasul Hooded and Protrusio Acetabular Inserts, Sulzer Orthopedics, Inc. (2000). Our reading of the summary gave K001526, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Centerpulse Orthopedics Epsilon Metasul Acetabular Insert, 28mm Hooded”.
- K002379: M2A 28MM Ringloc Liner, Biomet, Inc. (2000) Summary page 1.
- K003363: M2A 32MM Taper System, Biomet, Inc. (2000) Summary page 1.
- K993438: Metal on Metal Acetabular System, Biomet, Inc. (2000) Summary page 1.
- K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 1.

## Most influential descendants
- K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads (2006), 74 descendants of its own
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K130899: Biolox Delta Ceramic Femoral Heads (2013), 19 descendants of its own

## Recalls of this device
- Dec 17, 2014 · Class II · Z-1133-2015: 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 con
- Jun 30, 2008 · Not classified · Z-2299-2008: The wrong part may be in the package. Package may contain a 28 mm head.

## Indications for use
The EpsilonTM Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following: patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, post-traumatic arthritis or avascular necrosis and inflammatory joint disease (IJD), e.g., rheumatoid arthiritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K033634
Methodology: https://510kreport.com/methodology