# K202326: BESPA Charcot System

- Pathway: 510(k) (Traditional)
- Applicant: Bespa Global, LLC
- Decided: Nov 9, 2021 after 449 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: 11 generations back to K962616 (1996). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140741: Salvation Beams and Bolts System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011) Summary page 4.

## Indications for use
The The BESPA Charcot System is indicated for fracture fixation, reconstruction procedures, arthrodesis, and osteotomies of various bones and bone fragments in the foot and ankle, including metatarsals and tarsals. For example, medial and/or lateral column fusion as a result of neuropathic osteoarthropathy (Charcot). The BEPSA Charcot System is intended for use in adult populations.

Source page: https://510kreport.com/device/K202326
Methodology: https://510kreport.com/methodology