# K971778: Osteo Small and Mini Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jun 27, 1997 after 44 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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) Synthes Small and Mini Cortex Screws: named in the summary without a submission number
- (no number) Howmedica Small and Mini Bone Screws: named in the summary without a submission number

## Indications for use
The subject Osteo Small and Mini Bone Screws are intended for internal fracture fixation of small bones. Osteo Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K971778
Methodology: https://510kreport.com/methodology