# K972403: Bti Cortical Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biodynamic Technologies, Inc.
- Decided: Aug 29, 1997 after 64 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063589: Gso Bone Fixation Fasteners (2007), 4 descendants of its own
- K071035: Ifs Bone Fixation Devices (2007), 3 descendants of its own
- K130613: Cannulated Screw and Kirschner (Kwire) System (2014), 1 descendant of its own
- K252758: Cannulated Screw and Kirschner (K wire) System (2025), 0 descendants of its own
- K140216: Orthopedic Fixation Systems (2014), 0 descendants of its own

## Indications for use
The BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malieolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTl Compression Hip Screw System, BT! Humeral Intramedullary Rod Systems, and the BTl Distal Femoral Intramedullary Rod System.

Source page: https://510kreport.com/device/K972403
Methodology: https://510kreport.com/methodology