# K981194: Futura Biomedical Flexible Great Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Jun 30, 1998 after 89 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: 1 generation back to K780132 (1978). 1 ancestor in all.
5 later devices descend from it; 2 cite 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)
- K780132: Implant, Hinge Toe, Flex., Dow Corning Corp. Healthcare Industries Materials (1978) Summary page 1.

## Most influential descendants
- 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
- K023562: Modification to Classic Great Toe Implant (2002), 0 descendants of its own

## Indications for use
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/K981194
Methodology: https://510kreport.com/methodology