510(k) · Cleared
ClearedBioPoly Radial Head Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioPoly, LLC · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Mar 13, 2024 as substantially equivalent to K183618 (Ignite Orthopedics, Inc., 2019) and 2 other predicates after a 126-day review. Its family tree reaches back 12 generations to 1987.
- Decided
- Mar 13, 2024
- Review
- 126 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K864492 (1987). 31 ancestors in all, the oldest K781870 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 8 generations between
- 3 generations backK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- 2 generations backK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
- 1 generation backK222964 BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
- This deviceK233592 BioPoly Radial Head ImplantBioPoly, LLC · 2024
Show all 12 generations
- Root · 12 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 11 generations backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- 10 generations backK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- 9 generations backK063370 Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc. · 2007
- 8 generations backK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- 7 generations backK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- 6 generations backK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
- 5 generations backK131377 Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2013
- 4 generations backK152454 HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. · 2016
- 3 generations backK190543 Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
- 2 generations backK203634 BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC · 2021
- 1 generation backK222964 BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC · 2022
- This deviceK233592 BioPoly Radial Head ImplantBioPoly, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −11 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| −10 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| −9 | K063370 | Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | 2007 | — |
| −8 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| −7 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| −6 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
| −5 | K131377 | Hemicap MTP Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2013 | — |
| −4 | K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | 2016 | — |
| −3 | K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | 2019 | — |
| −2 | K203634 | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | 2021 | — |
| −1 | K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | 2022 | — |
| 0 (this device) | 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 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 KWI? 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 KWI device
- #1 K260624 Arthrex Radial Head Replacement Systemscore 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K183618 | Revolution Radial Head | 2019 |
| Kept off the family tree | K132735 | FDA’s K132735 is Axia Radial Head System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2014 |
| * | K203634 | BioPoly Great Toe Hemiarthroplasty ImplantSummary page 4…KWI _ 7 �K_132 I _ 3_ 5_ ____� AxiaRadialHead System KWI K203634 BioPoly Great ToeHemiarthroplasty Implant KWD K22296 4… | 2021 |
| * | K222964 | BioPoly Lesser Toe Hemiarthroplasty ImplantSummary page 4…KWI K203634 BioPoly Great ToeHemiarthroplasty Implant KWD K22296 4 BioPoly Lesser ToeHemiarthroplasty Implant KWD Device Descripti… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K183618.
How does its category compare?
All KWI devicesKWI Prosthesis, Elbow, Hemi-, Radial, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KWI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KWI
Too few KWI 510(k)s in any year since 2007 to give a median.
Recalls per year · KWI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWI
118in 2025
MAUDE reports naming product code KWI, 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 | 0 | — | 0 | 15 |
| 2008 | 0 | — | 0 | 16 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 1 | 31 |
| 2014 | 1 | — | 1 | 29 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 138 |
| 2017 | 1 | — | 1 | 360 |
| 2018 | 0 | — | 0 | 202 |
| 2019 | 1 | — | 0 | 214 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 1 | — | 0 | 44 |
| 2022 | 1 | — | 2 | 44 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 1 | — | 0 | 124 |
| 2025 | 0 | — | 0 | 118 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BioPoly Radial Head Implant is indicated for:
* Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
o joint destruction and/or subluxation visible on x-ray; and/or
o resistance to conservative treatment
* Primary replacement after fracture of the radial head
» Symptomatic sequelae after radial head resection
* Revision following failed radial head arthroplasty
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/K233592 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233592: BioPoly Radial Head Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233592
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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