# K983509: Inter-OP Acetabular System - Durasul Acetabular Insert

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Feb 3, 1999 after 119 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955033 (1996). 1 ancestor in all.
327 later devices descend from it; 2 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)
- K955033: Rim Flare Acetabular Component, Intermedics Orthopedics (1996) Summary page 1.

## Most influential descendants
- K993259: Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads (2000), 326 descendants of its own
- 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

## Indications for use
The DURASUL acetabular insert is a snap-in acetabular shell liner that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The insert is available in three styles and is intended to be used in conjunction with an Inter-Op acetabular shell to replace the acetabulum during total hip arthroplasty. Inter-Op acetabular components (shell/insert combination) may be implanted with or without bone cement. Diagnostic indications for use of this device include: patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. those patients with failed previous surgery where pain, deformity, or dysfunction persists. revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K983509
Methodology: https://510kreport.com/methodology