510(k) · Cleared
ClearedInion Freedompin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion OY · HTY Pin, Fixation, Smooth
Cleared on Apr 11, 2014 as substantially equivalent to K050275 (Inion, Ltd., 2005) after a 109-day review. Its family tree reaches back 3 generations to 1990. 4 later devices descend from it.
- Decided
- Apr 11, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901456 (1990). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 2 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 1 generation backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- This deviceK133932 Inion FreedompinInion OY · 2014
- Descendant · cites it directly · 3 of its ownK250646 Impact PEEK Union Nail SystemNvision Biomedical Technologies · 2025
- Descendant · 2 generations on · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
- Descendant · 2 generations on · 0 of its ownK252657 Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies · 2025 · cites it directly3descendants
- K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026 · 2 generations on1descendant
- K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026 · 3 generations on0descendants
- K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −2 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −1 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| 0 (this device) | K133932 | Inion Freedompin | Inion OY | 2014 | — |
| +1 | K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025 | — |
| +2 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| +3 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K050275 | Modification to: Inion Otps Biodegradable PinSummary page 1…Common name: Bone fixation pin Regulation number: 888.3040 Predicate device Inion OTPS Biodegradable Pin (K050275) Conformance with performance Compliance to voluntary consensus standards is listed in the standards… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250646 | Impact PEEK Union Nail System | 2025 | 3 |
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 24 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K250646 (Nvision Biomedical Technologies, 2025) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K050275.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 INION FreedomPlum products are 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/K133932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133932: Inion Freedompin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133932
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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