510(k) · Cleared
ClearedBio2 Fusion Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio2 Technologies, Inc. · HTY Pin, Fixation, Smooth
Cleared on Dec 30, 2015 as substantially equivalent to K050259 (Arthrex, Inc., 2005) and 3 other predicates after a 174-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Dec 30, 2015
- Review
- 174 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K960978 (1996). 67 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 5 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 4 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 3 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 2 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 1 generation backK142463 Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc. · 2014
- This deviceK151876 Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −5 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −4 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −3 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −2 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −1 | K142463 | Bio2 CLM BG Bioactive Scaffold | Bio2 Technologies, Inc. | 2014 | — |
| 0 (this device) | K151876 | Bio2 Fusion Implant System | Bio2 Technologies, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K050259 | Arthrex Bio-PinSummary page 4…888.3040! Regulatory&Class:& II! Product&Code:& HTY! ! III. Predicate!Device! ! Predicate&Device:& Arthrex,!!BioIPin!K050259! & Bio2,!!Bio2!CLM•BG!Bioactive!Scaffold!K142463! XtremiIT,!ReFIX… | 2005 |
| * | K142463 | Bio2 CLM BG Bioactive ScaffoldSummary page 4…HTY! ! III. Predicate!Device! ! Predicate&Device:& Arthrex,!!BioIPin!K050259! & Bio2,!!Bio2!CLM•BG!Bioactive!Scaffold!K142463! XtremiIT,!ReFIX!Internal!Fixation!Pins!!K043339! Wright,!!Medi… | 2014 |
| * | K043339 | Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Summary page 4…BioIPin!K050259! & Bio2,!!Bio2!CLM•BG!Bioactive!Scaffold!K142463! XtremiIT,!ReFIX!Internal!Fixation!Pins!!K043339! Wright,!!Medical!Phalinx!K142585! ! IV. !Device!Description! ! The!Bio2!Technologies!Fu… | 2005 |
| * | K142585 | PhaLinx Hammertoe SystemSummary page 4…G!Bioactive!Scaffold!K142463! XtremiIT,!ReFIX!Internal!Fixation!Pins!!K043339! Wright,!!Medical!Phalinx!K142585! ! IV. !Device!Description! ! The!Bio2!Technologies!Fusion!Implant!is!a!cylindrical!shaped!implant!designed!for! fracture… | 2014 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 67 ancestors have a recall of any class.
- 15 other devices also cite its predicate K050259.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Bio2 Fusion Implant System is indicated for fracture fixation, osteotomies, and inter-digital fusion of the fingers, toes and small bones in the presence of appropriate immobilization.
When used in the foot (including hammertoe, claw toe, and mallet toe) patients should use protected weight bearing or heel bearing until fusion or healing has occurred.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151876: Bio2 Fusion Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151876
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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