# K012762: MJS Posterior Stabilized Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Osteoimplant Technology, Inc.
- Decided: Dec 11, 2001 after 116 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- 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 MJS Posterior Stabilized Knee System is indicated for use in total knee replacement procedures for patients suffering from: • Rheumatoid arthritis. • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. • Failed osteotomies, unicompartmental replacement, or total knee replacement. The Posterior stabilized system is intended for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact and extra joint stability is required.

Source page: https://510kreport.com/device/K012762
Methodology: https://510kreport.com/methodology