# K884739: Sgarlato Lesser Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Sgarlato Laboratories, Inc.
- Decided: May 18, 1989 after 185 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.
4 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022886: Metatarsophalangeal Flexible Stabilizing Rod System (2002), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K884739
Methodology: https://510kreport.com/methodology