# K030923: Epsilon Durasul Constrained Acetabular Liner

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Oct 3, 2003 after 193 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P960047 (1997). 3 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960054: S-Rom Poly-Dial Constrained Liner, Depuy, A Johnson & Johnson Co. (1997) Summary page 1.
- P960047: Osteonics Constrained Acetabular Insert, Howmedica Osteonics Corp. (1997) Summary page 1.
- K021661: Ringloc Constrained Liners, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K071718: Trilogy Longevity Constrained Liner (2007), 28 descendants of its own
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners (2010), 23 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K122641: Mpact Extension (2012), 14 descendants of its own
- K132879: Mpact Extension (2014), 11 descendants of its own

## Indications for use
The Epsilon™ Durasul® Constrained Acetabular Insert is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.

Source page: https://510kreport.com/device/K030923
Methodology: https://510kreport.com/methodology