# K974756: Bti Large (7.0MM) Cannulated Transfixing Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biodynamic Technologies, Inc.
- Decided: Mar 12, 1998 after 83 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 no predicate by number.

## Indications for use
The BTI™ brand Large (7.0 mm) Cannulated Transfixing Screw is indicated for single use with the BTI brand Proximal Humeral Intramedullary Rod, the BTI brand Mid-Shaft Humeral Intramedullary Rod and the BT brand Distal Femoral Intramedutltary Rod Systems to stabliize fractures.

Source page: https://510kreport.com/device/K974756
Methodology: https://510kreport.com/methodology