510(k) · Cleared
Recalled · Class II · 2022Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopro, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Nov 12, 2004 after a 151-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it. It has been recalled 10 times.
- Decided
- Nov 12, 2004
- Review
- 151 days
- Class
- Class II
- Product code
- KWD
- Recalls
- 10
- Predicates
- 0
21 later devices descend from it, 7 citing it directly.
- This deviceK041595 Toe MP Joint, Models 10412-10414, 14958, 14960…Biopro, Inc. · 2004
- Descendant · cites it directly · 16 of its ownK060536 Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006
- Descendant · cites it directly · 15 of its ownK073065 Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008
- Descendant · 2 generations on · 13 of its ownK081876 Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008
- Descendant · cites it directly · 12 of its ownK083469 Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 2009
- Descendant · cites it directly · 11 of its ownK102401 Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP · 2006 · cites it directly16descendants
- K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP · 2008 · cites it directly15descendants
- K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP · 2008 · 2 generations on13descendants
- K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg · 2009 · cites it directly12descendants
- K102401Hemi Implant; Mini Hemi ImplantVilex, Inc. · 2011 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041595 | Toe MP Joint, Models 10412-10414, 14958, 14960… | Biopro, Inc. | 2004 | — |
| +1 | K060536 | Osteomed 1ST MPJ Hemi Implant System | Osteomed LP | 2006 | — |
| +1 | K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed LP | 2008 | — |
| +2 | K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed LP | 2008 | — |
| +1 | K083469 | Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000 | Metasurg | 2009 | — |
| +1 | K102401 | Hemi Implant; Mini Hemi Implant | Vilex, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (21)
See all 217 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060536 | Osteomed 1ST MPJ Hemi Implant System | 2006 | 16 |
| K073065 | Osteomed Metatarsal Resurfacing Implant System | 2008 | 15 |
| K083469 | Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000 | 2009 | 12 |
| K102401 | Hemi Implant; Mini Hemi Implant | 2011 | 11 |
| K121973 | Biopro Hemi-Edge Toe System | 2012 | 2 |
| K182704 | WishBone Guided Growth System | 2019 | 0 |
| K063058 | Arthrex Anatoemic Phalangeal Prosthesis | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2022 | Class II | Z-0686-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0684-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0685-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0690-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0682-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0683-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0687-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0688-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0689-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
| Feb 1, 2022 | Class II | Z-0691-2022 | Labeling design | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060536 (Osteomed LP, 2006) has gone furthest, with 16 descendants of its own.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
A) A press fit implant for arthritic degradation of the metatarso-phalangeal joint
that has resulted in disabling pain, limited motion and loss of the normal
ambulatory function of the forefoot.
B) Degenerative arthritis
C) Rheumetoid arthritis
D) Bunion deformity associated with arthritis of the metatarsal-phalangeal joint
E) The titanium version is available for use only in patients susceptible to nickel
chromium allergies.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041595 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041595
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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