510(k) · Cleared
ClearedActivapin HT, Fuse Link (Private Labled for Footmind, Inc.)
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 Jan 22, 2014 as substantially equivalent to K061164 (Bioretec, Ltd., 2006) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Jan 22, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K901456 (1990). 8 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 backK061164 ActivapinBioretec, Ltd. · 2006
- 1 generation backK080879 Activatm Product Group Including Bioabsorbable Devices Activapin…Bioretec, Ltd. · 2008
- This deviceK133950 Activapin HT, Fuse Link (Private Labled for Footmind, Inc.)Bioretec, Ltd. · 2014
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 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| −1 | K080879 | Activatm Product Group Including Bioabsorbable Devices Activapin Fusion… | Bioretec, Ltd. | 2008 | — |
| 0 (this device) | K133950 | Activapin HT, Fuse Link (Private Labled for Footmind, Inc.) | Bioretec, Ltd. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K061164 | ActivapinSummary page 3…ts have the same intended use and principles of operation, and also the same technological characteristic and performance as the previously cleared Bioretec ActivaPin"' (K061164) and Bioretec ActivaPinT m Product Group (KOBOB7S). Any differences between modified Bioretec ActivaPinm products and predicate d… | 2006 |
| * | K080879 | Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm…Summary page 2…d ActivaPin' TM Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin"' Product group 510(k) (K080879) adds one trade name; Bioretec ActivaPin TI HT in the ActivaPin"" Product Group. That device has a small modification to ActivaPi… | 2008 |
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 24 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 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. 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 devices of Blometec: ActivaPln' Product Group including ActivaPinm, ActivaPinN Fusion, AetivaNal' Conical, ActivaNaiM Flat and ActlvaPnM HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immoblization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133950: Activapin HT, Fuse Link (Private Labled for Footmind, Inc.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133950
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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