# K972323: Osteo Bos System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 10, 1997 after 82 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.
42 later devices descend from it; 4 cite it directly.
0 of 43 devices 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 bone screws offered by Synthes: named in the summary without a submission number

## Most influential descendants
- K023360: Leforte System Bone Plate (2002), 20 descendants of its own
- K123964: Axsos 3 TI Locking Plate System (2013), 19 descendants of its own
- K133440: Axsos 3 TI Locking Plate System Line Extension (2013), 12 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

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

Source page: https://510kreport.com/device/K972323
Methodology: https://510kreport.com/methodology