# K173286: Cannulated Screw Internal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 14, 2017 after 59 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 K014154 (2002). 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)
- K081149: Biopro GO-EZ Screw, Biopro, Inc. (2008) Summary page 4.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 4.

## Cited in the summary but kept off the family tree
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Cannulated Screw Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically: • Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions • Ligament reconstruction • Osteochondritis dissecans • Arthrodesis of the foot, ankle, wrist, elbow and hand • Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Source page: https://510kreport.com/device/K173286
Methodology: https://510kreport.com/methodology