# K143596: Miniars Screws

- Pathway: 510(k) (Traditional)
- Applicant: Overmed Srl.
- Decided: Feb 5, 2016 after 414 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 K050636 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 4.

## Indications for use
MINIARS screw system is intended for fixation of intra-articular and extra-articular fractures, non-union and osteotomies of small bones and small bone fragments. Some examples include: - arthrodesis of small joints (foot and hand surgery); - intra-articular metatarsal and metacarpal fractures; - osteotomies for hallux valgus treatment.

Source page: https://510kreport.com/device/K143596
Methodology: https://510kreport.com/methodology