# K062103: Darco Force Titanium Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Darco International, Inc.
- Decided: Oct 25, 2006 after 93 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: 1 generation back to K042079 (2004). 1 ancestor in all.
49 later devices descend from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042079: Oss/(Scarf)- and Osw-Screw, O.M.T. Oberflachen-Und Materialtechnologie GmbH (2004) Summary page 1.

## Most influential descendants
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins (2009), 48 descendants of its own
- K112727: Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical (2012), 9 descendants of its own
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), 8 descendants of its own
- K102845: Mahe Fixation Plate and Screw System (2011), 8 descendants of its own
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires (2014), 5 descendants of its own

## Indications for use
The DARCO Force Titanium Compression Screw is to be used on indications that are common for currently marketed compression screws. The primary indication for use is the fixation and stabilization of the fractures and non-unions of small bones and small bone arthrodeses including but not limited to intra-articular fractures of the tarsals, metatarsal, carpals and metacarpals, bunionectomies and osteotomies, arthrodesis of small joints (e.g. phalanges).

Source page: https://510kreport.com/device/K062103
Methodology: https://510kreport.com/methodology