# K931155: Staple, Fixation Bone; Screw Fixation Bone

- Pathway: 510(k) (Traditional)
- Applicant: Roseburg SA
- Decided: Sep 1, 1994 after 541 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.
551 later devices descend from it; 3 cite it directly.
1 of 552 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
- K962236: Scarf Thread-Head Screw (1996), 548 descendants of its own
- K062352: FRS Screw (2006), 527 descendants of its own
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own

Source page: https://510kreport.com/device/K931155
Methodology: https://510kreport.com/methodology