510(k) · Cleared
ClearedGreat Toe Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signal Medical Corp. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Jul 1, 2002 as substantially equivalent to K911378 (Biopro, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 1, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K823405 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK823405 Zimmer Great ToeZimmer, Inc. · 1983
- This deviceK021063 Great Toe ImplantSignal Medical Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823405 | Zimmer Great Toe | Zimmer, Inc. | 1983 | — |
| 0 (this device) | K021063 | Great Toe Implant | Signal Medical Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K911378 | Townley Great Toe JointSummary page 1…the distal end or hcad o f the first metatarsal bone. The design is made available in multiple sixes equivalent to the toe implants in the ’TownleyGreat Toe Joint 5 IOK (K911378) and the Zimnier Great Toe 510K (K823405). Indications for use 1. Osteoarthritis 2. Where the use ofa m… | 1991 |
| * | K823405 | Zimmer Great ToeSummary page 1…tarsal bone. The design is made available in multiple sixes equivalent to the toe implants in the ’TownleyGreat Toe Joint 5 IOK (K911378) and the Zimnier Great Toe 510K (K823405). Indications for use 1. Osteoarthritis 2. Where the use ofa more consemativc procedure has failed or i… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K911378.
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 | — |
What is it indicated for?
Osteoarthritis
Where the use of a more conservative procedure has failed or is unacceptable,
The device is intended for non-cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021063: 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/K021063
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026