510(k) · Cleared
ClearedCannulated Hemi Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex IN Tennessee, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on May 31, 2019 as substantially equivalent to K023684 (Vilex, Inc., 2004) and 5 other predicates after an 88-day review. Its family tree reaches back 9 generations to 1987. 5 later devices descend from it.
- Decided
- May 31, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K864492 (1987). 25 ancestors in all, the oldest K781870 (1979). 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 5 generations between
- 3 generations backK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- 2 generations backK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- 1 generation backK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- This deviceK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
- Descendant · cites it directly · 1 of its ownK222964 BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
- Descendant · cites it directly · 1 of its ownK200951 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK233592 BioPoly Radial Head ImplantBioPoly, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK240268 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 8 generations backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- 7 generations backK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- 6 generations backK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- 5 generations backK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- 4 generations backK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- 3 generations backK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- 2 generations backK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- 1 generation backK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- This deviceK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021 · cites it directly2descendants
- K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022 · cites it directly1descendant
- K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2020 · cites it directly1descendant
- K233592BioPoly Radial Head ImplantBioPoly, LLC · 2024 · 2 generations on0descendants
- K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −8 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| −7 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| −6 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| −5 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| −4 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| −3 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| −2 | K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2013 | — |
| −1 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| 0 (this device) | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
| +1 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021 | — |
| +1 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022 | — |
| +1 | K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2020 | — |
| +2 | K233592 | BioPoly Radial Head Implant | BioPoly, LLC | 2024 | — |
| +2 | K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023684 | Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565…Summary page 4…510(k) Clearance No. Date Cannulated Metallic Hemi Toe Implant Vilex, Inc. K023684 03/01/2004 Met-Head K070052 03/28/2007 Cannulated Metallic Hemi Impla… | 2004 |
| * | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC CannulationSummary page 4…No. Date Cannulated Metallic Hemi Toe Implant Vilex, Inc. K023684 03/01/2004 Met-Head K070052 03/28/2007 Cannulated Metallic Hemi Implant K102401 07/20/2011 HemiCAP MTP Resurfacing Hemi-… | 2007 |
| * | K102401 | Hemi Implant; Mini Hemi ImplantSummary page 4…K023684 03/01/2004 Met-Head K070052 03/28/2007 Cannulated Metallic Hemi Implant K102401 07/20/2011 HemiCAP MTP Resurfacing Hemi- Arthrosurface, Inc. K152454 04/11/2016 Arthroplasty System CAP Great… | 2011 |
| * | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemSummary page 4…K070052 03/28/2007 Cannulated Metallic Hemi Implant K102401 07/20/2011 HemiCAP MTP Resurfacing Hemi- Arthrosurface, Inc. K152454 04/11/2016 Arthroplasty System CAP Great Toe Resurfacing Hemi- Arthrosurface, Inc. K031859 02/18/2004 Arthroplasty… | 2016 |
| * | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantSummary page 4…11 HemiCAP MTP Resurfacing Hemi- Arthrosurface, Inc. K152454 04/11/2016 Arthroplasty System CAP Great Toe Resurfacing Hemi- Arthrosurface, Inc. K031859 02/18/2004 Arthroplasty Implant Arthrosurface Toemotion Arthrosurface, Inc. K132496 02/26/2014 IV. Device De… | 2004 |
| * | K132496 | Arthrosurface ToemotionSummary page 4…stem CAP Great Toe Resurfacing Hemi- Arthrosurface, Inc. K031859 02/18/2004 Arthroplasty Implant Arthrosurface Toemotion Arthrosurface, Inc. K132496 02/26/2014 IV. Device Description The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to res… | 2014 |
What descends from it? (5)
3 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 32 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K203634 (BioPoly, LLC, 2021) has gone furthest, with 2 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. 2019, 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 CHI (cannulated 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 Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with 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/K190543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190543: Cannulated 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/K190543
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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