# K954330: Super Screw 3.5 MM

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Dec 8, 1995 after 84 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.
464 later devices descend from it; 4 cite it directly.
1 of 465 devices in its family (counting itself) has 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
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System (2006), 310 descendants of its own
- K063298: Osteomed Headless Cannulated Screw System (2007), 246 descendants of its own
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own

Source page: https://510kreport.com/device/K954330
Methodology: https://510kreport.com/methodology