# K082320: Darco Small Screw

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 5, 2008 after 84 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.
302 later devices descend from it; 18 cite it directly.
1 of 303 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 no predicate by number.

## Most influential descendants
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw (2010), 97 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
- K112772: Ortholoc (TM) Bone Screws (2011), 68 descendants of its own

## Indications for use
The WRIGHTTM Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Source page: https://510kreport.com/device/K082320
Methodology: https://510kreport.com/methodology