# K183094: CyclaPlex Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Cycla Orthopedics, Ltd.
- Decided: Apr 26, 2019 after 170 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K792022 (1979). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091763: Michelangelo Bunion System - Mabs, Model: MA6000, Instratek, Inc. (2009) Summary page 4.

## Indications for use
The CyclaPlex Correction System is intended for the following surgical indications: to assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle.

Source page: https://510kreport.com/device/K183094
Methodology: https://510kreport.com/methodology