# K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins

- Pathway: 510(k) (Traditional)
- Applicant: Treu-Instrumente GmbH
- Decided: Jul 15, 2009 after 197 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: 6 generations back to K962823 (1996). 34 ancestors in all.
48 later devices descend from it; 11 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983006: Osteo 5.0MM Cannulated Screw System, Stryker Osteonics (1998) Summary page 2.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 2.
- K062103: Darco Force Titanium Compression Screw, Darco International, Inc. (2006) Summary page 2.
- K062352: FRS Screw, DePuy Orthopaedics, Inc. (2006) Summary page 2.
- K002605: 4.0/2.5 MM Self-Drilling Schanz Screw, Synthes (Usa) (2000) Summary page 2.
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 2.
- K030665: Bone Wire, Stork Instrumente GmbH (2003) Summary page 2.
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 2.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 2.

## Most influential descendants
- 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
- K112254: Apex Kirschner Wires and Steinmann Pins (2011), 5 descendants of its own

## Indications for use
The Treu Bone Fixation Screws and Pins are intended to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K083912
Methodology: https://510kreport.com/methodology