# K203773: BRM TOOL Screws

- Pathway: 510(k) (Traditional)
- Applicant: Brm Extremities Srl
- Decided: Jan 14, 2022 after 387 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
Longest line of descent: 13 generations back to K962616 (1996). 201 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163489: OrthoSolutions 'System26' Bone Screws, Ortho Solutions UK Limited (2017) Summary page 5.

## Most influential descendants
- K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant (2022), 0 descendants of its own

## Indications for use
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.

Source page: https://510kreport.com/device/K203773
Methodology: https://510kreport.com/methodology