# K012739: Converge Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Nov 14, 2001 after 90 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
No predicates in its family tree.
247 later devices descend from it; 1 cites it directly.
0 of 248 devices 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) Sulzer Orthopedics Inter-Op Acetabular System: named in the summary without a submission number
- (no number) Zimmer Trilogy Acetabular System: named in the summary without a submission number
- (no number) Stryker/Osteonics/Howmedica System 12 Acetabular System: named in the summary without a submission number
- (no number) Smith & Nephew Orthopaedics Reflection Acetabular System: named in the summary without a submission number
- (no number) DePuy Duraloc Acetabular System: named in the summary without a submission number

## Most influential descendants
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System (2009), 246 descendants of its own
- K093846: Longevity IT Highly Crosslinked Polyethylene Elevated Liners (2010), 144 descendants of its own
- K101229: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper (2010), 143 descendants of its own
- K103662: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI (2011), 137 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own

## Indications for use
Components of the Converge Acetabular System are intended for use in total hip arthroplasty for treatment of the following: 1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 3. Revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K012739
Methodology: https://510kreport.com/methodology