# K201830: ANSER Clavicle Pin

- Pathway: 510(k) (Traditional)
- Applicant: BAAT Medical Products B.V.
- Decided: Aug 27, 2020 after 56 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960642 (1996). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182783: DePuy Synthes Trauma Orthopedic Nail Implants, DePuy Synthes (2018) Summary page 5.
- K163488: Flex-Thread Clavicle Pin System, Intrafuse, LLC (2017) Summary page 5.

## Indications for use
The ANSER Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Source page: https://510kreport.com/device/K201830
Methodology: https://510kreport.com/methodology