510(k) · Cleared
ClearedHemi Implant; Mini Hemi Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Jul 20, 2011 as substantially equivalent to K023684 (Vilex, Inc., 2004) and 4 other predicates after a 330-day review. Its family tree reaches back 6 generations to 1987. 11 later devices descend from it.
- Decided
- Jul 20, 2011
- Review
- 330 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K864492 (1987). 16 ancestors in all, the oldest K781870 (1979). 11 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 5 generations backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- 4 generations backK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- 3 generations backK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- 2 generations backK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- 1 generation backK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- This deviceK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK222964 BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013 · cites it directly9descendants
- K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016 · 2 generations on6descendants
- K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019 · cites it directly5descendants
- K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021 · 2 generations on2descendants
- K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −5 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| −4 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| −3 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| −2 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| −1 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| 0 (this device) | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| +1 | K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2013 | — |
| +2 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| +1 | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
| +2 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021 | — |
| +2 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023684 | Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565…Summary page 1…ame: Cannulated Metallic Hemi Implant Classification: 21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis, KWD K023684 Vilex Cannulated Metallic Hemi Implant Predicate Devices: K(041595 BioPro Hemi Joint with option… | 2004 |
| * | K041595 | Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Summary page 1…- Toe joint phalangeal (hemi-toe) polymer prosthesis, KWD K023684 Vilex Cannulated Metallic Hemi Implant Predicate Devices: K(041595 BioPro Hemi Joint with optional coating K(911378 Townley Great Toe Joint8: Bio… | 2004 |
| Kept off the family tree | K091378 | FDA’s K091378 is Mammosite II Radiation Therapy System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K083469 | Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000 Our reading of the summary gave K084369, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Metasurg Hemi Joint”. | 2009 |
| * | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingSummary page 1…K(911378 Townley Great Toe Joint8: BioPro K(084369 Metasurg Hemi Joint K(081876 OsteoMed Resurfacing Metatarsal Implant with HA Coating… | 2008 |
| * | K971047 | Futura Biomedical Metal Hemi Toe ImplantSummary page 1…K(081876 OsteoMed Resurfacing Metatarsal Implant with HA Coating K(971047 FUTURA Biomedical Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to D… | 1997 |
What descends from it? (11)
See all 114 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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K131377 (Arthrosurface, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K023684.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidlus, and an unstable or painful MTP joint.
The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.
The Vilex cannulated metallic hemi implant is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102401: Hemi Implant; Mini Hemi Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102401
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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