# K982903: Sulzer Orthopedics Fluted Stems

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Oct 21, 1998 after 64 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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) Maxim Constrained Knee (Biomet): named in the summary without a submission number
- (no number) Coordinate Revision Knee (DePuy): named in the summary without a submission number
- (no number) Kinemax Plus Super Stabilizer (Howmedica): named in the summary without a submission number
- (no number) PFC - TC3 (Johnson and Johnson): named in the summary without a submission number

## Most influential descendants
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own

## Indications for use
The Sulzer Orthopedics Fluted Stems are intended for cemented use in the following diagnostic indications: 1. Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis). 2. Correctable valgus-varus deformity and moderate flexion contracture. 3. Those patients with failed previous surgery where pain, deformity, or dysfunction persist. 4. Revision of previously failed knee arthroplasty.

Source page: https://510kreport.com/device/K982903
Methodology: https://510kreport.com/methodology