510(k) · Cleared
ClearedClassic 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 Oct 4, 2002 as substantially equivalent to K981194 (Nexa Orthopedics, Inc., 1998) after a 17-day review. Its family tree reaches back 2 generations to 1978. 1 later device descends from it.
- Decided
- Oct 4, 2002
- Review
- 17 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K780132 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK780132 Implant, Hinge Toe, Flex.Dow Corning Corp. Healthcare Industries Materials · 1978
- 1 generation backK981194 Futura Biomedical Flexible Great Toe ImplantNexa Orthopedics, Inc. · 1998
- This deviceK023086 Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK023562 Modification to Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K023562Modification to Classic Great Toe ImplantNexa Orthopedics, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780132 | Implant, Hinge Toe, Flex. | Dow Corning Corp. Healthcare Industries Materials | 1978 | — |
| −1 | K981194 | Futura Biomedical Flexible Great Toe Implant | Nexa Orthopedics, Inc. | 1998 | — |
| 0 (this device) | K023086 | Classic Great Toe Implant | Nexa Orthopedics, Inc. | 2002 | — |
| +1 | K023562 | Modification to Classic Great Toe Implant | Nexa Orthopedics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K981194 | Futura Biomedical Flexible Great Toe ImplantSummary page 1…87 K W Original Predicate Device: Futura Biomedical Flexible Great Toe Implant - k98 1 194 Registration Number: 2030833 Owner Opemtor Number: 90283 19 Device Descrip… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023562 | Modification to Classic Great Toe Implant | 2002 | 0 |
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?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 20.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K023562 (Nexa Orthopedics, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K981194.
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?
Futura Biomedical Classic Great Toe Implant is indicated for:
Hallux l'mitus or hallux rigidus
Painful rheumatoid arthritis
Hallux abduct0 valgus associated with arthritis
Unstable or painfid joint from previous surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023086: Classic 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/K023086
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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