510(k) · Cleared
ClearedImplant, Hinge Toe, Flex.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dow Corning Corp. Healthcare Industries Materials · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Feb 6, 1978 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 6, 1978
- Review
- 13 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK780132 Implant, Hinge Toe, Flex.Dow Corning Corp. Healthcare Industries Materials · 1978
- Descendant · cites it directly · 5 of its ownK981194 Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc. · 1998
- Descendant · 2 generations on · 2 of its ownK153609 RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK023086 Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK191966 NewPrim SystemBrm Extremities · 2020
- Descendant · 3 generations on · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K981194Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc. · 1998 · cites it directly5descendants
- K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016 · 2 generations on2descendants
- K023086Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002 · 2 generations on1descendant
- K191966NewPrim SystemBrm Extremities · 2020 · 3 generations on0descendants
- K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K780132 | Implant, Hinge Toe, Flex. | Dow Corning Corp. Healthcare Industries Materials | 1978 | — |
| +1 | K981194 | Futura Biomedical Flexible Great Toe Implant | Nexa Orthopedics, Inc. | 1998 | — |
| +2 | K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016 | — |
| +2 | K023086 | Classic Great Toe Implant | Nexa Orthopedics, Inc. | 2002 | — |
| +3 | K191966 | NewPrim System | Brm Extremities | 2020 | — |
| +3 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 KWH? 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 KWH device
- #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981194 | Futura Biomedical Flexible Great Toe Implant | 1998 | 5 |
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?
- Of its descendants, K981194 (Nexa Orthopedics, Inc., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWH
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KWH
Too few KWH 510(k)s in any year since 2007 to give a median.
Recalls per year · KWH
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWH
8in 2025
MAUDE reports naming product code KWH, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K780132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K780132: Implant, Hinge Toe, Flex..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K780132
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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