510(k) · Cleared
ClearedOrthropro Hemi Toe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopro, LLC · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Nov 13, 2006 as substantially equivalent to K971047 (Nexa Orthopedics, Inc., 1997) and 2 other predicates after a 47-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Nov 13, 2006
- Review
- 47 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864492 (1987). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 1 generation backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- This deviceK062908 Orthropro Hemi ToeOrthopro, LLC · 2006
- Descendant · cites it directly · 0 of its ownK071243 Metal Hemi ImplantOrthopro, LLC · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K071243Metal Hemi ImplantOrthopro, LLC · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −1 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| 0 (this device) | K062908 | Orthropro Hemi Toe | Orthopro, LLC | 2006 | — |
| +1 | K071243 | Metal Hemi Implant | Orthopro, LLC | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (3)
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 |
|---|---|---|---|
| * | K971047 | Futura Biomedical Metal Hemi Toe ImplantSummary page 1…Class II per 21 CFR section 888.3730 Product Code KWD Equivalent Device Futura Biomedical Metal Hemi Toe Implant (K97 1047) Kinetikos Medical K2 Hemni Toe Implant System (K023770) Townley Grea… | 1997 |
| * | K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Summary page 1…KWD Equivalent Device Futura Biomedical Metal Hemi Toe Implant (K97 1047) Kinetikos Medical K2 Hemni Toe Implant System (K023770) Townley Great Toe Joint (K91 1378) Device Description The Ortho/Pro Hemi Toe is a single stemmed r… | 2002 |
| * | K911378 | Townley Great Toe JointSummary page 1…Hemi Toe Implant (K97 1047) Kinetikos Medical K2 Hemni Toe Implant System (K023770) Townley Great Toe Joint (K91 1378) Device Description The Ortho/Pro Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071243 | Metal Hemi Implant | 2007 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K071243 (Orthopro, LLC, 2007) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K971047.
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?
The Ortho/Pro Hemi Toe is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062908: Orthropro Hemi Toe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062908
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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