# K950704: K4 Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Jun 30, 1995 after 135 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.
40 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K120493: Mini Cannulated Headed and Headless Screw Set (2012), 39 descendants of its own
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own

Source page: https://510kreport.com/device/K950704
Methodology: https://510kreport.com/methodology