# K864492: Swanson Titanium Great Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Dow Corning Wright
- Decided: Apr 15, 1987 after 153 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- 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.
29 later devices descend from it; 2 cite it directly.
0 of 30 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
- K971047: Futura Biomedical Metal Hemi Toe Implant (1997), 28 descendants of its own
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant (2004), 23 descendants of its own
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation (2007), 18 descendants of its own
- K063370: Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty (2007), 16 descendants of its own
- K060536: Osteomed 1ST MPJ Hemi Implant System (2006), 16 descendants of its own

## Recalls of this device
- Nov 8, 2016 · Class II · Z-0562-2020: The firm discovered a lack of adequate documentation confirming sterility on certain products.

Source page: https://510kreport.com/device/K864492
Methodology: https://510kreport.com/methodology