510(k) · Cleared
ClearedBioPoly Great Toe Hemiarthroplasty Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioPoly, LLC · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Feb 2, 2021 as substantially equivalent to K070052 (Vilex, Inc., 2007) and 1 other predicate after a 53-day review. Its family tree reaches back 10 generations to 1987. 2 later devices descend from it.
- Decided
- Feb 2, 2021
- Review
- 53 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K864492 (1987). 26 ancestors in all, the oldest K781870 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 6 generations between
- 3 generations backK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- 2 generations backK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- 1 generation backK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- This deviceK203634 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 · 0 of its ownK233592 BioPoly Radial Head ImplantBioPoly, LLC · 2024
Show all 10 generations
- Root · 10 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 9 generations backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- 8 generations backK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- 7 generations backK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- 6 generations backK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- 5 generations backK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- 4 generations backK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- 3 generations backK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- 2 generations backK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- 1 generation backK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- This deviceK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −9 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| −8 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| −7 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| −6 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| −5 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| −4 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| −3 | 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 | — |
| 0 (this device) | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021 | — |
| +1 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022 | — |
| +1 | K233592 | BioPoly Radial Head Implant | BioPoly, LLC | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC CannulationSummary page 4…Manufacturer Device Name K Number Met-Head™, Resurfacing Hemi-Arthroplasty Implant K070052 Primary Vilex Cannulated Hemi Implants K190543… | 2007 |
| * | K190543 | Cannulated Hemi ImplantSummary page 4…Resurfacing Hemi-Arthroplasty Implant K070052 Primary Vilex Cannulated Hemi Implants K190543 Reference Dow Corning H.P. Condylar Implant K781870… | 2019 |
| † | K781870 | Implant, H.P. Condylar | 1979 |
What descends from it? (2)
2 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 34 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K222964 (BioPoly, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K070052.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 BioPoly Great Toe Hemiarthroplasty implant is intended to be implanted to replace the distal metatarsal surface of the great toe 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/K203634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203634: BioPoly Great Toe Hemiarthroplasty Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203634
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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