# K153609: RTS Flexible 1 MPJ Implant w/Grommets

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Sep 8, 2016 after 266 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: 2 generations back to K780132 (1978). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981194: Futura Biomedical Flexible Great Toe Implant, Nexa Orthopedics, Inc. (1998) Summary page 4.

## Most influential descendants
- K191966: NewPrim System (2020), 0 descendants of its own
- K190385: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System (2019), 0 descendants of its own

## Indications for use
The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of: Hallux limitus or hallux rigidus Painful rheumatoid arthritis Hallux abducto valgus associated with arthritis Unstable or painful joint from previous surgery

Source page: https://510kreport.com/device/K153609
Methodology: https://510kreport.com/methodology