# K012961: Sulzer Orthopedics Converge Acetabular System

- Pathway: 510(k) (Special)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Oct 18, 2001 after 44 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Inter-Op Acetabular System: named in the summary without a submission number

## Indications for use
Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following: o patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IID), e.g., rheumatoid arthritis. those patients with failed previous surgery where pain, deformity, or dysfunction persists. revision of a previously failed arthroplasty where there is sufficient bone stock to support the implant.

Source page: https://510kreport.com/device/K012961
Methodology: https://510kreport.com/methodology