# K191817: ActivOrtho Continuous Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Activortho, Inc.
- Decided: Jul 26, 2019 after 21 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 K962011 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181610: ActivOrtho Nitinol Compression Screw System, Activortho, Inc. (2019) Summary page 4.
- 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.

## Indications for use
The ActivOrtho Continuous 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/K191817
Methodology: https://510kreport.com/methodology