# K011262: Modification to the Bold Screw

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Jun 15, 2001 after 51 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.
547 later devices descend from it; 4 cite it directly.
1 of 548 devices in its family (counting itself) has 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
- 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
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own

Source page: https://510kreport.com/device/K011262
Methodology: https://510kreport.com/methodology