# K143229: Nexis osteosynthesis compressive screws

- Pathway: 510(k) (Traditional)
- Applicant: Novastep
- Decided: Feb 6, 2015 after 88 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). 10 ancestors in all.
3 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)
- K070039: Memometal Fixos Screws, Memometal Technologies (2007) Summary page 5.
- K052576: Sbi Autofix, Small Bone Innovations, LLC (2005) Summary page 4.

## Most influential descendants
- K223468: Nexis® compressive screws (2023), 0 descendants of its own
- K230397: Cut Screw - Percutaneous Compression Screw (2023), 0 descendants of its own
- K221090: Metal Cannulated Screw (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K143229
Methodology: https://510kreport.com/methodology