# K250536: MetaFore Small Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Oct 8, 2025 after 226 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: 3 generations back to K091118 (2009). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153182: Self- Compressive Screw, Neosteo (2015) Summary page 5.
- K150772: Snap-Off Self-Compressive Screw, Neosteo (2015) Summary page 5.

## Indications for use
The MetaFore Small Screw System is indicated for the fixation of bone fractures and for bone reconstruction in hand and forefoot surgery.

Source page: https://510kreport.com/device/K250536
Methodology: https://510kreport.com/methodology