# K042079: Oss/(Scarf)- and Osw-Screw

- Pathway: 510(k) (Traditional)
- Applicant: O.M.T. Oberflachen-Und Materialtechnologie GmbH
- Decided: Dec 20, 2004 after 140 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.
50 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062103: Darco Force Titanium Compression Screw (2006), 49 descendants of its own
- 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

## Indications for use
Fixation and stabilization of bones of the feet; such as: Akin-Osteotomie, Scarf-Osteotomie, Chevron-Austin-Osteotomie, MPG-Arthrodesis, Closing-Wedge Osteotomie. The Scarf screw can be used for the fixation of almost all common osteotomies of the first metatarsal. Fixation and stabilization of bones of the feet; such as Weil-Osteotomie

Source page: https://510kreport.com/device/K042079
Methodology: https://510kreport.com/methodology