# K181610: ActivOrtho Nitinol Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Activortho, Inc.
- Decided: Mar 12, 2019 after 266 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: 2 generations back to K962011 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160427: dynaMX (TM) Nitinol Compression Screw, Mx Orthopedics, Corp. (2016) Summary page 4.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K973309: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Vilex, Inc. (1998) Summary page 4.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 4.

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

## Indications for use
The ActivOrtho Nitinol Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.

Source page: https://510kreport.com/device/K181610
Methodology: https://510kreport.com/methodology