# K163148: BePOD® Foot Screws

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Sep 14, 2017 after 309 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: 1 generation back to K052576 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 4.

## Indications for use
BePOD 3A cannulated screws are designed for the following indications: - Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy. - Compressive osteosynthsis of fractures of several bones in the forefoot. BePOD percutaneous cannulated screws are designed for the following indications: - Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy. - Compressive osteosynthesis of fractures of several bones in the forefoot.

Source page: https://510kreport.com/device/K163148
Methodology: https://510kreport.com/methodology