# K191966: NewPrim System

- Pathway: 510(k) (Traditional)
- Applicant: Brm Extremities
- Decided: Feb 13, 2020 after 205 days
- Product code: KWH (Prosthesis, Toe, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3720
- 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 K780132 (1978). 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)
- K153609: RTS Flexible 1 MPJ Implant w/Grommets, In2bones USA, LLC (2016) Summary page 5.

## Indications for use
The BRM Extremities NewPrim device is intended for use in: - Hallux rigidus or hallux limitus; - Painful rheumatoid arthritis; - Hallux abducto valgus associated with arthritis; - Unstable or painful joint from previous surgery

Source page: https://510kreport.com/device/K191966
Methodology: https://510kreport.com/methodology