# K043583: Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 26, 2005 after 29 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.
191 later devices descend from it; 7 cite it directly.
1 of 192 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wright Pre-amendment No. 223 Knowles Pin: named in the summary without a submission number

## Most influential descendants
- K050819: Charlotte Snap-Off Screw (2005), 178 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K043583
Methodology: https://510kreport.com/methodology