# K993259: Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Mar 10, 2000 after 163 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955033 (1996). 2 ancestors in all.
326 later devices descend from it; 5 cite it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983509: Inter-OP Acetabular System - Durasul Acetabular Insert, Sulzer Orthopedics, Inc. (1999) Summary page 1.

## Most influential descendants
- K022902: Smith & Nephew Hip System (2002), 285 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K043079: Bicontact Hip System with U-Cap (2004), 166 descendants of its own
- K022958: Total Hip Femoral Heads and Liners (2002), 162 descendants of its own

## Recalls of this device
- Feb 27, 2023 · Class II · Z-1294-2023: Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the
- Dec 17, 2014 · Class II · Z-1132-2015: 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
- Sep 4, 2012 · Class II · Z-0222-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## Indications for use
The Inter-Op Durasul Acetabular Components and CoCr Femoral Heads are intended for use in treatment of the following: 1. Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis. Fracture or avascular necrosis of the femoral head. 3. Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty and total hip replacement.

Source page: https://510kreport.com/device/K993259
Methodology: https://510kreport.com/methodology