# K223468: Nexis® compressive screws

- Pathway: 510(k) (Abbreviated)
- Applicant: Novastep
- Decided: Aug 30, 2023 after 286 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
Longest line of descent: 4 generations back to K792022 (1979). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133451: Fixos Screw System, Stryker Trauma AG (2014) Summary page 4.
- K080850: Darco Headless Compression Screw, Wrightmedicaltechnologyinc (2008) Summary page 4.
- K143229: Nexis osteosynthesis compressive screws, Novastep (2015) Summary page 4.

## Indications for use
Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for: 05.0mm compressive screw: - Os Calcis and talar fractures - Calcaneus osteotomies - Arthrodesis of the tarsals 07.0mm compressive screw: - Ankle arthrodesis - Calcaneus osteotomies

Source page: https://510kreport.com/device/K223468
Methodology: https://510kreport.com/methodology