510(k) · Cleared
ClearedFutura Biomedical Flexible Great Toe Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexa Orthopedics, Inc. · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Jun 30, 1998 as substantially equivalent to K780132 (Dow Corning Corp. Healthcare Industries Materials, 1978) after an 89-day review. Its family tree reaches back 1 generation to 1978. 5 later devices descend from it.
- Decided
- Jun 30, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K780132 (1978). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK780132 Implant, Hinge Toe, Flex.Dow Corning Corp. Healthcare Industries Materials · 1978
- This deviceK981194 Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK153609 RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016
- Descendant · cites it directly · 1 of its ownK023086 Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK191966 NewPrim SystemBrm Extremities · 2020
- Descendant · 2 generations on · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK023562 Modification to Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002
Most influential descendants
Showing 5 of 5 · See all- K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC · 2016 · cites it directly2descendants
- K023086Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002 · cites it directly1descendant
- K191966NewPrim SystemBrm Extremities · 2020 · 2 generations on0descendants
- K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC · 2019 · 2 generations on0descendants
- K023562Modification to Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780132 | Implant, Hinge Toe, Flex. | Dow Corning Corp. Healthcare Industries Materials | 1978 | — |
| 0 (this device) | K981194 | Futura Biomedical Flexible Great Toe Implant | Nexa Orthopedics, Inc. | 1998 | — |
| +1 | K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016 | — |
| +1 | K023086 | Classic Great Toe Implant | Nexa Orthopedics, Inc. | 2002 | — |
| +2 | K191966 | NewPrim System | Brm Extremities | 2020 | — |
| +2 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
| +2 | K023562 | Modification to Classic Great Toe Implant | Nexa Orthopedics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 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? (1)
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 |
|---|---|---|---|
| * | K780132 | Implant, Hinge Toe, Flex.Summary page 1…nstrained Polymer Toe Prosthesis per 888.3720 (Class 1) Substantially Equivalent to (predicate device): Swanson Flexible Hinge Toe Implant by Dow Corning, 510(k) number K780132 (now offered by Wright Medical Technology, Inc., Arlington, TN). Description/Intended Use: The Flexible Great Toe implant is a d… | 1978 |
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K153609 (In2bones USA, LLC, 2016) has gone furthest, with 2 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 | — |
What is it indicated for?
Hallux limitus or hallux rigidus.
Painful rheumatoid arthritis.
Hallux abducto valgus associated with arthritis.
Unstable or painful joint from previous surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981194: Futura Biomedical Flexible Great Toe Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981194
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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