510(k) · Cleared
ClearedModification to: Inion Otps Biodegradable Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion, Ltd. · HTY Pin, Fixation, Smooth
Cleared on Mar 7, 2005 as substantially equivalent to K031712 (Inion, Ltd., 2003) after a 28-day review. Its family tree reaches back 2 generations to 1990. 51 later devices descend from it.
- Decided
- Mar 7, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K901456 (1990). 4 ancestors in all. 51 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 1 generation backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- This deviceK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- Descendant · cites it directly · 37 of its ownK061164 ActivapinBioretec, Ltd. · 2006
- Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- Descendant · 3 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 4 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
- Descendant · 5 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K061164ActivapinBioretec, Ltd. · 2006 · cites it directly37descendants
- K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
- K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 3 generations on16descendants
- K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 4 generations on15descendants
- K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −1 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| 0 (this device) | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| +1 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| +2 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| +3 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +4 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
| +5 | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K031712 | Inion Otps Biodegradable PinSummary page 1…ion fastener Regulatory Class: Class II Product Code: HTY PREDICATE DEVICE Inion OTPS TMI Biodegradable Pin (K03 1712) CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance standards exist for thi… | 2003 |
What descends from it? (51)
See all 513 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 15 years and passes through 2 companies; a new generation was cleared every 13.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061164 (Bioretec, Ltd., 2006) has gone furthest, with 37 descendants of its own.
- 6 other devices also cite its predicate K031712.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OTPSTM Biodegradable Pin 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/K050275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050275: Modification to: Inion Otps Biodegradable Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050275
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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