# K905795: Sgarlato Flexible Hinge Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Sgarlato Laboratories, Inc.
- Decided: May 29, 1991 after 153 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K102601: Orthoflex Rod (2011), 0 descendants of its own

## Recalls of this device
- Mar 1, 2009 · Not classified · Z-2173-2010: Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The outer and inner packa

Source page: https://510kreport.com/device/K905795
Methodology: https://510kreport.com/methodology