510(k) · Cleared
Recalled · 2009Lesser Metatarsal Phalangeal Joint 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 Jan 17, 2003 as substantially equivalent to K820813 (Sutter Biomedical, Inc., 1982) after an 88-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 17, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- KWH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K820813 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK820813 Lesser Metatarsal Phalang. Joint ProsthSutter Biomedical, Inc. · 1982
- This deviceK023531 Lesser Metatarsal Phalangeal Joint ImplantNexa Orthopedics, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK173491 RTS Lesser MTP Implant SystemIn2bones USA, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820813 | Lesser Metatarsal Phalang. Joint Prosth | Sutter Biomedical, Inc. | 1982 | — |
| 0 (this device) | K023531 | Lesser Metatarsal Phalangeal Joint Implant | Nexa Orthopedics, Inc. | 2003 | — |
| +1 | K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K820813 | Lesser Metatarsal Phalang. Joint ProsthSummary page 1…87 KWH Original Predicate Device: Sutter Lesser Metatarsal Phalangeal Joint Prosthesis K 820813, Currently sold by Futura Biomedical Registration Number:… | 1982 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173491 | RTS Lesser MTP Implant System | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2009 | Not classified | Z-0455-2010 | Labeling mix-ups | Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K173491 (In2bones USA, LLC, 2018) has gone furthest, with 1 descendant 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?
Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for:
Partial or complete dislocation of the lesser metatarsophalangeal joint
Pain Associated with rheumatoid or osteo-arthritis
Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
Stiffness at the lesser metatarsophalangeal joint associated with joint disease
Kohler’s disease
Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023531: Lesser Metatarsal Phalangeal Joint Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023531
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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