510(k) · Cleared
ClearedCap Great Toe Resurfacing Hemi-Arthroplasty Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Feb 18, 2004 as substantially equivalent to K781870 (Dow Corning Corp. Healthcare Industries Materials, 1979) and 4 other predicates after a 247-day review. Its family tree reaches back 2 generations to 1987. 23 later devices descend from it.
- Decided
- Feb 18, 2004
- Review
- 247 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K864492 (1987). 6 ancestors in all, the oldest K781870 (1979). 23 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 1 generation backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- This deviceK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- Descendant · cites it directly · 18 of its ownK070052 Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007
- Descendant · cites it directly · 16 of its ownK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- Descendant · cites it directly · 15 of its ownK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- Descendant · 2 generations on · 13 of its ownK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- Descendant · 3 generations on · 11 of its ownK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007 · cites it directly18descendants
- K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007 · cites it directly16descendants
- K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008 · cites it directly15descendants
- K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008 · 2 generations on13descendants
- K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −1 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| 0 (this device) | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| +1 | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation | Vilex, Inc. | 2007 | — |
| +1 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| +1 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| +2 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| +3 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K781870 | Implant, H.P. CondylarSummary page 2…lasty implant, has been compared with the following legally marketed device to which the submitter claims equivalence. * Implant, H.P. condylar, Dow Corning Wright (K781870) * Swanson Titanium Great Toe Implant, Dow Corning Wright (K864492) * K2 Hemi-Toe Implant System, Kinetikos Medical, Inc.… | 1979 |
| * | K864492 | Swanson Titanium Great Toe ImplantSummary page 2…vice to which the submitter claims equivalence. * Implant, H.P. condylar, Dow Corning Wright (K781870) * Swanson Titanium Great Toe Implant, Dow Corning Wright (K864492) * K2 Hemi-Toe Implant System, Kinetikos Medical, Inc. (K023770) · Futura Biomedical Metal Hemi Toe Implant, Futura Biome… | 1987 |
| * | K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Summary page 2…condylar, Dow Corning Wright (K781870) * Swanson Titanium Great Toe Implant, Dow Corning Wright (K864492) * K2 Hemi-Toe Implant System, Kinetikos Medical, Inc. (K023770) · Futura Biomedical Metal Hemi Toe Implant, Futura Biomedical(K971047) · Townley Great Toe Joint, Biopro, lnc.(K911378)… | 2002 |
| * | K971047 | Futura Biomedical Metal Hemi Toe ImplantSummary page 2…plant, Dow Corning Wright (K864492) * K2 Hemi-Toe Implant System, Kinetikos Medical, Inc. (K023770) · Futura Biomedical Metal Hemi Toe Implant, Futura Biomedical(K971047) · Townley Great Toe Joint, Biopro, lnc.(K911378) Device Description and Implantation Summary The CAP TM Great Toe Resurfaci… | 1997 |
| * | K911378 | Townley Great Toe JointSummary page 2…Implant System, Kinetikos Medical, Inc. (K023770) · Futura Biomedical Metal Hemi Toe Implant, Futura Biomedical(K971047) · Townley Great Toe Joint, Biopro, lnc.(K911378) Device Description and Implantation Summary The CAP TM Great Toe Resurfacing Hemi-arthroplasty implant is a cobalt chrome alloy… | 1991 |
What descends from it? (23)
See all 239 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation | 2007 | 18 |
| K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | 2007 | 16 |
| K073065 | Osteomed Metatarsal Resurfacing Implant System | 2008 | 15 |
| K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | 2013 | 9 |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | 2016 | 6 |
| K190543 | Cannulated Hemi Implant | 2019 | 5 |
| K090127 | Metatarsal Decompression Implant, Model 100 | 2009 | 2 |
| K092047 | Ascension Metal Great Toe System | 2010 | 1 |
| K063058 | Arthrex Anatoemic Phalangeal Prosthesis | 2007 | 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 17 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K070052 (Vilex, Inc., 2007) has gone furthest, with 18 descendants of its own.
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?
Hemi-arthroplasty implant for first metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
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/K031859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031859
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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