# K032348: Converge Reti-Lock Multi-Hole Reinforcement Cup

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Oct 24, 2003 after 86 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K980774 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022985: Ascendent Acetabular System, Sulzer Orthopedics, Inc. (2002) Summary page 1.
- K980774: Osteonics Gap-II Restoration Acetabular Shells, Osteonics Corp. (1998) Summary page 1.

## Indications for use
The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following: 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/K032348
Methodology: https://510kreport.com/methodology