510(k) · Cleared
Recalled · Class II · 2016Swanson Titanium Great Toe Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dow Corning Wright · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Apr 15, 1987 after a 153-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it. It has been recalled once.
- Decided
- Apr 15, 1987
- Review
- 153 days
- Class
- Class II
- Product code
- KWD
- Recalls
- 1
- Predicates
- 0
29 later devices descend from it, 2 citing it directly.
- This deviceK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987
- Descendant · cites it directly · 28 of its ownK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- Descendant · cites it directly · 23 of its ownK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- Descendant · 2 generations on · 18 of its ownK070052 Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007
- Descendant · 2 generations on · 16 of its ownK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- Descendant · 2 generations on · 16 of its ownK060536 Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K971047Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997 · cites it directly28descendants
- K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004 · cites it directly23descendants
- K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007 · 2 generations on18descendants
- K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007 · 2 generations on16descendants
- K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | — |
| +1 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| +1 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| +2 | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation | Vilex, Inc. | 2007 | — |
| +2 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| +2 | K060536 | Osteomed 1ST MPJ Hemi Implant System | Osteomed LP | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWD device
- #1 K250074 HYALEX® MTP Hemiarthroplasty Implantscore 13.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2016 | Class II | Z-0562-2020 | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971047 (Nexa Orthopedics, Inc., 1997) has gone furthest, with 28 descendants of its own.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KWD
47in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWD
10in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWD
8in 2025
MAUDE reports naming product code KWD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 65 | 0 | 0 |
| 2008 | 3 | 84 | 1 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 47 | 0 | 1 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 1 | — | 1 | 7 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 10 | 10 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 133 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K864492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864492: Swanson Titanium Great Toe Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864492
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026