# K143146: Nexis osteosynthesis snap-off screws

- Pathway: 510(k) (Traditional)
- Applicant: Novastep
- Decided: Feb 6, 2015 after 95 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: 3 generations back to K792022 (1979). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070039: Memometal Fixos Screws, Memometal Technologies (2007) Summary page 4.

## Most influential descendants
- K220921: Metal Bone Screw (2022), 1 descendant of its own
- K242348: Locking Screw,CoCrMo (2024), 0 descendants of its own

## Indications for use
The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.

Source page: https://510kreport.com/device/K143146
Methodology: https://510kreport.com/methodology