# K160427: dynaMX (TM) Nitinol Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Mx Orthopedics, Corp.
- Decided: Jun 3, 2016 after 108 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: 1 generation back to K050636 (2005). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 4.

## Most influential descendants
- K181610: ActivOrtho Nitinol Compression Screw System (2019), 1 descendant of its own
- K191817: ActivOrtho Continuous Compression Screw System (2019), 0 descendants of its own

## Indications for use
The dynaMX™ Nitinol Compression Screw is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The implants are intended for single use only.

Source page: https://510kreport.com/device/K160427
Methodology: https://510kreport.com/methodology