510(k) · Cleared
ClearedImpact PEEK Union Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies · HTY Pin, Fixation, Smooth
Cleared on Jun 11, 2025 as substantially equivalent to K133932 (Inion OY, 2014) and 1 other predicate after a 99-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Jun 11, 2025
- Review
- 99 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K901456 (1990). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 3 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 2 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- 1 generation backK133932 Inion FreedompinInion OY · 2014
- This deviceK250646 Impact PEEK Union Nail SystemNvision Biomedical Technologies · 2025
- Descendant · cites it directly · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
- Descendant · cites it directly · 0 of its ownK252657 Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026 · cites it directly1descendant
- K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026 · 2 generations on0descendants
- K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −3 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −2 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| −1 | K133932 | Inion Freedompin | Inion OY | 2014 | — |
| 0 (this device) | K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025 | — |
| +1 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| +2 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026 | — |
| +1 | K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 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 |
|---|---|---|---|
| * | K133932 | Inion FreedompinSummary page 6…edicate Device Name / Manufacturer Primary Predicate K133932 Inion FreedomPin ✓ K181180 OSSIO Pin Product Family S… | 2014 |
| * | K181180 | OSSIO™ Pin Product FamilySummary page 6…Predicate K133932 Inion FreedomPin ✓ K181180 OSSIO Pin Product Family SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the Impa… | 2019 |
What descends from it? (3)
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 35 years and passes through 4 companies; a new generation was cleared every 11.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K253718 (Nvision Biomedical Technologies, Inc., 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250646: Impact PEEK Union Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250646
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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