# K990513: Ultimax Cortical Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biodynamic Technologies, Inc.
- Decided: Mar 17, 1999 after 27 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ULTIMAX™ 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 malleolus and distal tibia; patelia 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 ULTiIMAX™ Humeral Intramedullary Rod System.

Source page: https://510kreport.com/device/K990513
Methodology: https://510kreport.com/methodology