# K062352: FRS Screw

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 19, 2006 after 69 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
Longest line of descent: 2 generations back to K792022 (1979). 6 ancestors in all.
527 later devices descend from it; 4 cite it directly.
1 of 534 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962236: Scarf Thread-Head Screw, Landos, Inc. (1996) Summary page 1.
- K011262: Modification to the Bold Screw, New Deal, S.A. (2001) Summary page 1.

## Most influential descendants
- 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
- K143039: CrossRoads Screw System (2015), 79 descendants of its own

## Indications for use
The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include: • Hallux Valgus correction • Akin Osteotomies • MTP arthrodesis • Interphalangeal arthrodesis

Source page: https://510kreport.com/device/K062352
Methodology: https://510kreport.com/methodology