# K983657: Osteonics Series 7000 AD Tibial Tray

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Apr 6, 2000 after 535 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. The FDA summary names its predicate without a number.
- (no number) Howmedica Osteonics® Series 7000 Total Knee System Tibial Components: named in the summary without a submission number
- (no number) Howmedica Osteonics® Omniflex™ AD Hip Stem: named in the summary without a submission number
- (no number) The Maxim® Complete Knee System - Biomet, Inc.: named in the summary without a submission number

## Indications for use
The subject devices are single use components, intended for cemented use only. The indications for the use of these tibial trays, in keeping with those of other legally marketed Howmedica Osteonics tibial trays, are as follows: Indications: L. 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. Additional Indications for Posterior Stabilized Components: . Ligmentous instability requiring implant bearing surface geometries with increased constraint. e Absent or non-functioning posterior cruciate ligament.

Source page: https://510kreport.com/device/K983657
Methodology: https://510kreport.com/methodology