510(k) · Cleared
ClearedOSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OSSIO, Ltd. · HTY Pin, Fixation, Smooth
Cleared on Oct 16, 2020 as substantially equivalent to K190652 (OSSIO, Ltd., 2020) after a 108-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Oct 16, 2020
- Review
- 108 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901456 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 4 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 3 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- 2 generations backK181180 OSSIO™ Pin Product FamilyOSSIO, Ltd. · 2019
- 1 generation backK190652 OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation…OSSIO, Ltd. · 2020
- This deviceK201803 OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation…OSSIO, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −4 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −3 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| −2 | K181180 | OSSIO™ Pin Product Family | OSSIO, Ltd. | 2019 | — |
| −1 | K190652 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant | OSSIO, Ltd. | 2020 | — |
| 0 (this device) | K201803 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant | OSSIO, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 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 |
|---|---|---|---|
| * | K190652 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantSummary page 4…d metallic bone fixation fastener Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HTY Predicate Devices OSSIOfiberTM Hammertoe Fixation System (K190652) Device Description The OSSIOfiberTM Hammertoe Fixation Systems\OSSIOfiberTM Hammertoe Fixation Implants include implants that… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 OSSIOfiberTM Hammertoe Fixation System/ OSSIOfiberTM Hammertoe Fixation Implant is indicated for
maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and 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/K201803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201803: OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201803
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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