# K973204: Osteo Bos System in Stainless Steel

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 25, 1997 after 30 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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) bone plates offered by Synthes: named in the summary without a submission number

## Indications for use
The indications for use of the Osteo BOS™ System in Stainless Steel bone plates, in keeping with those of other legally marketed bone plates and bone screws, are as follows. The Osteo BOS™ System in Stainless Steel components are intended for long and small bone fracture fixation.

Source page: https://510kreport.com/device/K973204
Methodology: https://510kreport.com/methodology