# K780132: Implant, Hinge Toe, Flex.

- Pathway: 510(k) (Traditional)
- Applicant: Dow Corning Corp. Healthcare Industries Materials
- Decided: Feb 6, 1978 after 13 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981194: Futura Biomedical Flexible Great Toe Implant (1998), 5 descendants of its own
- K153609: RTS Flexible 1 MPJ Implant w/Grommets (2016), 2 descendants of its own
- K023086: Classic Great Toe Implant (2002), 1 descendant of its own
- 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

Source page: https://510kreport.com/device/K780132
Methodology: https://510kreport.com/methodology