510(k) · Cleared
ClearedActivapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioretec, Ltd. · HTY Pin, Fixation, Smooth
Cleared on Aug 31, 2007 as substantially equivalent to K061164 (Bioretec, Ltd., 2006) after a 56-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Aug 31, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901456 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 backK061164 ActivapinBioretec, Ltd. · 2006
- This deviceK071863 Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)Bioretec, Ltd. · 2007
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 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| 0 (this device) | K071863 | Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS) | Bioretec, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K061164 | ActivapinSummary page 1…AUG 3 1200? G SPECIAL 510(k) SUMMARY For the modification to Bioreltec ActivaPinTM (K061164) MANUFACTURER Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND Contact person: Ms. Marl Ruotsalainen Q… | 2006 |
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 17 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.
- 5 other devices also cite its predicate K061164.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ActivaPinTM is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071863: Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071863
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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