# K060478: Arthrex Bio-Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 19, 2006 after 85 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
No predicates in its family tree.
27 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K132217: Arthrex Compression FT Screws (2013), 18 descendants of its own
- K193660: OSSIOfiber™ Compression Screws (2020), 6 descendants of its own
- K150456: Arthrex Plates, Screws, and Staples (2015), 6 descendants of its own
- K221193: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (2022), 4 descendants of its own
- K213596: OSSIOfiber Compression Screw, 3.5mm (2021), 4 descendants of its own

## Indications for use
The Arthrex Blo-Compression Screw is intended for fixation of fractures, osteotomies and arthrodesis in: * Carpal, metacarpal, and small hand bone * tarsal and metatarsals * phalanges Intra-articular fractures * ankle * proximal and distal humerus * proximal and distal radius * proximal and distal ulna * osteochondral fixation and fractures. Osteochondritis Dissecans * Fixation of fractures and osteotomies about the knee * Oblique fractures of the fi'bula * Reconstructive surgeries of the fool: * malleolar fixation where size of offered implant is patient appropriate.

Source page: https://510kreport.com/device/K060478
Methodology: https://510kreport.com/methodology