# K980999: ST Leger Cemented Semi-Constrained Total Knee Implant

- Pathway: 510(k) (Traditional)
- Applicant: Instrument Makar, Inc.
- Decided: Nov 6, 1998 after 233 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The specific intended use of the St. Leger total knee implant is for patients suffering from pain and/or deformity of the knee joint. The pathological conditions include, but are not limited to severe degenerative arthritis, traumatic arthritis, inflammatory arthritis, and rheumatoid arthritis. The symptomatic problems include pain, decreased ambulation, inability to work, perform activities of daily living. The resulting physical deformities include loss of knee extension, knee flexion, genu valgum and genu varus. The implant may be used in revision knee surgery due to loosening, infection, or prior implant failure if the proper accompanying conditions are present and the surgeon is able to make the necessary anatomical conditions for acceptable alignment and fixation.

Source page: https://510kreport.com/device/K980999
Methodology: https://510kreport.com/methodology