# K921481: Interference-Cannu-Flex/Silk Screws-Screw DR/G Wir

- Pathway: 510(k) (Traditional)
- Applicant: Acufex Microsurgical, Inc.
- Decided: Aug 24, 1993 after 512 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040331: Smith and Nephew Titanium Interference Screws (2004), 10 descendants of its own
- K083619: Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020 (2009), 7 descendants of its own
- K091093: Parcus Ppek CF Interference Screw (2009), 4 descendants of its own
- K180573: Responsive Arthroscopy Interference Screw System (2018), 2 descendants of its own
- K170877: Parcus SLiK Fix Screw (2017), 1 descendant of its own

## Recalls of this device
- Apr 8, 2021 · Class II · Z-1510-2021: Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw

Source page: https://510kreport.com/device/K921481
Methodology: https://510kreport.com/methodology