# K080850: Darco Headless Compression Screw

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 10, 2008 after 15 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.
17 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K133460: Aptus Cannulated Compression Screws (2013), 8 descendants of its own
- K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System (2020), 6 descendants of its own
- K133451: Fixos Screw System (2014), 3 descendants of its own
- K211783: TriMed Threaded Intramedullary Nail System (2021), 2 descendants of its own
- K200291: CREED™ Cannulated Screws (2020), 2 descendants of its own

## Indications for use
The 7.0mm DARCO® Headless 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 tibio fibular diastasis * Hindfoot arthrodesis The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: * Mono or Bi-Cortical osteotomies in the foot or hand * Distal or Proximal metatarsal or metacarpal osteotomies * Weil osteotomy * Fusion of the first metatarsophalangeal joint and interphalangeal joint * Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) * Akin type osteotomy * Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus * Calcaneus/ cuboid arthrodesis * Talar/ navicular arthrodesis

Source page: https://510kreport.com/device/K080850
Methodology: https://510kreport.com/methodology