# K112727: Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical

- Pathway: 510(k) (Traditional)
- Applicant: Medical Facets
- Decided: Jan 13, 2012 after 115 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: 7 generations back to K962823 (1996). 38 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 2.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 2.
- K911505: Fixation Wire, Simpex, Inc. (1991) Summary page 2.
- K051605: Sbi K-Wires, Small Bone Innovations, LLC (2005) Summary page 2.

## Most influential descendants
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires (2014), 5 descendants of its own
- K163487: Ultima HA Coated Half Pins and Wire (2017), 4 descendants of its own
- K243798: Orthex External Fixation System (2025), 1 descendant of its own
- K202054: Dynex Ring Fixation System, Diametrix Ring Fixation System (2020), 1 descendant of its own
- K132248: Flower Bone Screw Set (2013), 1 descendant of its own

## Indications for use
The Medical Facet Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fuision, bone reconstruction, or as guide pins for insertion of other implantable devices

Source page: https://510kreport.com/device/K112727
Methodology: https://510kreport.com/methodology