# K991143: Magna-Rom 21 Knee Systeem

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Jun 11, 1999 after 67 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.
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) Sulzer Orthopedics Natural-Knee II System: named in the summary without a submission number
- (no number) Apollo Knee System: named in the summary without a submission number

## Indications for use
The Magna-ROM 21 Knee System is intended for replacement of the knee joint during total knee arthroplasty. Components of the Magna-ROM system are intended for use only with bone cement. Specific diagnostic indications include: 1. Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis). 2. Patient conditions of noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis). 3. Correctable valgus-varus deformity and moderate flexion contracture. 4. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 5. Revision of previously failed knee arthroplasty.

Source page: https://510kreport.com/device/K991143
Methodology: https://510kreport.com/methodology