# K050819: Charlotte Snap-Off Screw

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 11, 2005 after 11 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 K043583 (2005). 1 ancestor in all.
178 later devices descend from it; 7 cite it directly.
1 of 180 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043583: Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003, Wrightmedicaltechnologyinc (2005) Summary page 2.

## Most influential descendants
- K133713: Charlotte (TM) Snap-Off Screw (2014), 83 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own

## Indications for use
The CHARLOTTE TM Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: * Fixation of Small Bone Fragments * Weil osteotomy * Mono-cortical fixation * Osteotomies and fractures fixation in the foot and hand

Source page: https://510kreport.com/device/K050819
Methodology: https://510kreport.com/methodology