# K914004: Alphatec Cannulated Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Mfg., Inc.
- Decided: Dec 5, 1991 after 90 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.
93 later devices descend from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K110472: SI-Fix Sacroiliac Joint Fusion System (2012), 92 descendants of its own
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems (2016), 79 descendants of its own
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (2018), 30 descendants of its own
- K191748: Genesys Spine Sacroiliac Joint Fusion System (2019), 22 descendants of its own
- K203247: iFuse-TORQ™ Implant System (2021), 17 descendants of its own

Source page: https://510kreport.com/device/K914004
Methodology: https://510kreport.com/methodology