# K022886: Metatarsophalangeal Flexible Stabilizing Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Nov 25, 2002 after 87 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 K884739 (1989). 1 ancestor in all.
3 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)
- K884739: Sgarlato Lesser Toe Implant, Sgarlato Laboratories, Inc. (1989) 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
- K102601: Orthoflex Rod (2011), 0 descendants of its own

## Indications for use
Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.

Source page: https://510kreport.com/device/K022886
Methodology: https://510kreport.com/methodology