# K210146: Cannulated Compression Device System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs North America, Inc.
- Decided: Apr 13, 2022 after 447 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 K000080 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 4.

## Indications for use
The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.

Source page: https://510kreport.com/device/K210146
Methodology: https://510kreport.com/methodology