510(k) · Cleared
ClearedBiopro Hemi-Edge Toe System
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 Oct 30, 2012 as substantially equivalent to K041595 (Biopro, Inc., 2004) and 1 other predicate after a 117-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Oct 30, 2012
- Review
- 117 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911378 (1991). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK911378 Townley Great Toe JointBiopro, Inc. · 1991
- This deviceK121973 Biopro Hemi-Edge Toe SystemBiopro, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK200951 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK240268 Accu-Joint Hemi ImplantAccufix Surgical, Inc. · 2024
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 |
|---|---|---|---|---|---|
| −1 | K911378 | Townley Great Toe Joint | Biopro, Inc. | 1991 | — |
| 0 (this device) | K121973 | Biopro Hemi-Edge Toe System | Biopro, Inc. | 2012 | — |
| +1 | K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2020 | — |
| +2 | K240268 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | 2024 | — |
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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K041595 | Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Summary page 1…e joint phalangeal (hemi-toe) prosthesis (2ICFR, Sec. 888.3730) DEVICE PRODUCT CODE: KWD SUBSTANTIALLY EQUIVALENT DEVICES 'BioPro Hemi MP Joint (K(041595) Townley Great Toe Joint (K(911378) DEVICE DESCRIPTION: The BioPro Hemi-Edge Toe System wi… | 2004 |
| * | K911378 | Townley Great Toe JointSummary page 1…DEVICE PRODUCT CODE: KWD SUBSTANTIALLY EQUIVALENT DEVICES 'BioPro Hemi MP Joint (K(041595) Townley Great Toe Joint (K(911378) DEVICE DESCRIPTION: The BioPro Hemi-Edge Toe System will be available in two material opt… | 1991 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200951 | Accu-Joint Hemi Implant | 2020 | 1 |
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. 2012, 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?
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.
Degenerative arthritis
Rheumetoid arthritis
Bunion deformity associated with arthritis of the metatarsal-phalangeal joint
A titanium version is available for use only in patients susceptible to nickel chromium allergies.
The BioPro Hemi-Edge Toe System is not intended for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121973: Biopro Hemi-Edge Toe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121973
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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