# K002575: Inter-OP Durasul Acetabular Inserts (4MM)

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Nov 15, 2000 after 89 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
326 later devices descend from it; 3 cite it directly.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K002575
Methodology: https://510kreport.com/methodology