# K110592: 3.7MM/5.0MM Dynamic Locking Screw

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA
- Decided: Jul 25, 2011 after 145 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961413 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101696: Motionloc Screw for NCB Polyaxial Locking Plating System, Zimmer, Inc. (2010) Summary page 1.
- K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 1.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.

## Recalls of this device
- Aug 11, 2015 · Class II · Z-2794-2015: DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaint
- Jul 22, 2013 · Class II · Z-0390-2014: All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the 

## Indications for use
Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

Source page: https://510kreport.com/device/K110592
Methodology: https://510kreport.com/methodology