# K002605: 4.0/2.5 MM Self-Drilling Schanz Screw

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 20, 2000 after 90 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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.
49 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K002605
Methodology: https://510kreport.com/methodology