# K973438: Osteo Bos System Product Line Extension

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 9, 1997 after 90 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 and Kirschner wires offered by Synthes: named in the summary without a submission number

## Indications for use
The indications for use of the Osteo BOS™ System bone plates and Kirschner wire, in keeping with those of other legally marketed bone plates and Kirschner wires, are as follows. The indications for each of the Osteo BOS™ System product line extension bone plates are: Internal fracture fixation of long and small bones. The indications for the Kirschner wires with a trocar point are: For use as guide wires in hip pinning procedures. For use in aligning and reducing long bone fractures. For use in securing non-long bone fractures such as olecranon fractures, patella fractures, tibial plateau fractures, small hand and foot bone fractures, humeral, and humeral, radial and ulnar fractures, etc. For use with cerclage wire/cable in treating greater trochanter fractures.

Source page: https://510kreport.com/device/K973438
Methodology: https://510kreport.com/methodology