# K210994: Arthrex Beveled FT Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 1, 2021 after 60 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 K000684 (2000). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162353: MICATM Screw System, Wrightmedicaltechnologyinc (2017) Summary page 4.
- K201132: Arthrex Compression Screws, Arthrex, Inc. (2020) Summary page 4.

## Indications for use
The Arthrex Beveled FT Screws are indicated for fixation of bone fractures or for bone reconstruction. Examples include: • Mono or Bi-Cortical osteotomies in the foot or hand • Distal or Proximal metatarsal or metacarpal osteotomies • Weil osteotomy • Fusion of the first metatarsophalangeal joint and interphalangeal joint • Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) • Akin type osteotomy • Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus • Calcaneus/cuboid arthrodesis • Talar/navicular arthrodesis

Source page: https://510kreport.com/device/K210994
Methodology: https://510kreport.com/methodology