# K150126: Life Spine Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: May 11, 2015 after 111 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: 6 generations back to K915818 (1992). 30 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009) Summary page 4.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K905048: Ace 3.5MM Cortical Bone Screw, Ace Medical Co. (1991) Summary page 4.

## Most influential descendants
- K153065: The Hammertoe Correction System (2016), 2 descendants of its own
- K171448: Hammertoe Correction System (2017), 0 descendants of its own
- K162685: 2-Piece Hammertoe Correction System (2017), 0 descendants of its own

## 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/K150126
Methodology: https://510kreport.com/methodology