# K043281: Charlotte High-Demand Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 19, 2005 after 54 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.
252 later devices descend from it; 2 cite it directly.
1 of 253 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) Newdeal I.C.O.S.® Screw: named in the summary without a submission number

## Most influential descendants
- K060071: Nexa Compression Screw (2006), 251 descendants of its own
- K063298: Osteomed Headless Cannulated Screw System (2007), 246 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own

## Indications for use
The High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: * Fixation of bone fragments, in long bones or small bones fractures * Fracture management in the foot or hand * Arthrodesis in hand. foot or ankle surgery * Mono or Bi-cortical osteotomies in the foot or hand or in long bones * Treatment of inferior tiblo fibular diastasis * Hindfoot arthrodesis

Source page: https://510kreport.com/device/K043281
Methodology: https://510kreport.com/methodology