# K973406: Osteonics Series 7000 Total Knee Augmented Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 8, 1997 after 90 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) Osteonics® Series 7000 Total Knee Posteriorly Stabilized Long Stem Femoral Component: named in the summary without a submission number

## Indications for use
The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation. The indications for use are: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss. 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, accompanied by bone loss. Ligamentous instability requiring implant bearing surface geometries with increased constraint. Absent or non-functioning posterior cruciate ligament.

Source page: https://510kreport.com/device/K973406
Methodology: https://510kreport.com/methodology