# K991461: Osteonics Scorpio Total Knee Relaxed Back P/S Tibial Bearing Insert

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 17, 1999 after 20 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
Longest line of descent: 1 generation back to K962152 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 1.

## Indications for use
The indications for the use of the Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert, in keeping with those of other legally marketed Osteonics® total knee components, are as follows: Indications : . Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. ° Post-traumatic loss of knee joint configuration and function. ] Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. ° Revision of previous unsuccessful knee replacement or other procedure. . Ligamentous instability requiring implant bearing surface geometries with increased constraint. . Absent or non-functioning posterior cruciate ligament.

Source page: https://510kreport.com/device/K991461
Methodology: https://510kreport.com/methodology