510(k) · Cleared
ClearedMetasurg Cannulated Tiatanium Hemi Implant, Model HM-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metasurg · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Feb 13, 2009 as substantially equivalent to K023684 (Vilex, Inc., 2004) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 2004. 12 later devices descend from it.
- Decided
- Feb 13, 2009
- Review
- 81 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023684 (2004). 2 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK023684 Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775…Vilex, Inc. · 2004
- This deviceK083469 Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 2009
- Descendant · cites it directly · 11 of its ownK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- Descendant · 2 generations on · 9 of its ownK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- Descendant · 3 generations on · 6 of its ownK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011 · cites it directly11descendants
- K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013 · 2 generations on9descendants
- K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016 · 3 generations on6descendants
- K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019 · 2 generations on5descendants
- K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023684 | Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675… | Vilex, Inc. | 2004 | — |
| 0 (this device) | K083469 | Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000 | Metasurg | 2009 | — |
| +1 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| +2 | K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2013 | — |
| +3 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| +2 | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
| +3 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (2)
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 1…tion is provided to demonstrate the MetaSurg hemi implant to be substantially equivalent to the Vilex hemi implant (K023684) and the BioPro hemi implant (K041595). The methods used to establish equivalence are indications for… | 2004 |
| * | K041595 | Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Summary page 1…taSurg hemi implant to be substantially equivalent to the Vilex hemi implant (K023684) and the BioPro hemi implant (K041595). The methods used to establish equivalence are indications for use, materi… | 2004 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102401 | Hemi Implant; Mini Hemi Implant | 2011 | 11 |
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. 2009, 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 MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.
The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.
The MetaSurg cannulated titanium hemi implant is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083469: Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083469
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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