510(k) · Cleared
ClearedFutura Biomedical Metal Hemi Toe Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexa Orthopedics, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Jun 20, 1997 as substantially equivalent to K864492 (Dow Corning Wright, 1987) after a 91-day review. Its family tree reaches back 1 generation to 1987. 28 later devices descend from it.
- Decided
- Jun 20, 1997
- Review
- 91 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864492 (1987). 28 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- This deviceK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- Descendant · cites it directly · 23 of its ownK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- Descendant · 2 generations on · 18 of its ownK070052 Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007
- Descendant · 2 generations on · 16 of its ownK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- Descendant · cites it directly · 16 of its ownK060536 Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006
- Descendant · 2 generations on · 15 of its ownK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004 · cites it directly23descendants
- K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007 · 2 generations on18descendants
- K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007 · 2 generations on16descendants
- K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006 · cites it directly16descendants
- K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| 0 (this device) | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| +1 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| +2 | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation | Vilex, Inc. | 2007 | — |
| +2 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| +1 | K060536 | Osteomed 1ST MPJ Hemi Implant System | Osteomed LP | 2006 | — |
| +2 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K864492 | Swanson Titanium Great Toe ImplantSummary page 1…Phalangeal Hemi-Toe Prosthesis per 888.3730 (Class Il) Substantially Equivalent to (predicate device): Swanson Titanium Great Toe Implant by Dow Corning, 510(k) number K864492 Description/Intended Use: The Metal Hemi Toe implant is a cobalt chrome alloy, one piece implant to supplement first metatarsal… | 1987 |
| † | K511378 | BIOPRO, INC. phalangeal hemi toe |
What descends from it? (28)
See all 286 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?
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?
Hallux limitus or hallux rigidous.
Painful hallux valgus.
Revision of failed previous surgery.
Painful arthritis.
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/K971047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971047: Futura Biomedical Metal Hemi 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/K971047
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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