# K023531: Lesser Metatarsal Phalangeal Joint Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Jan 17, 2003 after 88 days
- Product code: KWH (Prosthesis, Toe, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820813 (1982). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820813: Lesser Metatarsal Phalang. Joint Prosth, Sutter Biomedical, Inc. (1982) Summary page 1.

## Most influential descendants
- K173491: RTS Lesser MTP Implant System (2018), 1 descendant of its own
- K190385: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System (2019), 0 descendants of its own

## Recalls of this device
- Apr 6, 2009 · Not classified · Z-0455-2010: Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier 

## Indications for use
Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint Pain Associated with rheumatoid or osteo-arthritis Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint Stiffness at the lesser metatarsophalangeal joint associated with joint disease Kohler’s disease Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state

Source page: https://510kreport.com/device/K023531
Methodology: https://510kreport.com/methodology