510(k) · Cleared
ClearedBio2 CLM BG Bioactive Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio2 Technologies, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 18, 2014 as substantially equivalent to K101860 (Novabone Products, LLC, 2010) and 3 other predicates after a 107-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Dec 18, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K960978 (1996). 31 ancestors in all, the oldest K852682 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 4 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 3 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 2 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 1 generation backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- This deviceK142463 Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK151876 Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −4 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −3 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −2 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −1 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| 0 (this device) | K142463 | Bio2 CLM BG Bioactive Scaffold | Bio2 Technologies, Inc. | 2014 | — |
| +1 | 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 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 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 |
|---|---|---|---|
| * | K101860 | Novabone Putty- Bioactive Synthetic Bone GraftSummary page 4…CFR 888.3045) Regulatory Class: II Product Code: MQV III. Predicate Device Predicate Device: NovaBone K101860 Inion BioRestore K090177 OsteoBiologics Inc. PolyGraft K033707… | 2010 |
| * | K090177 | Inion Biorestore Biodegradable Bone Graft SubstituteSummary page 4…II Product Code: MQV III. Predicate Device Predicate Device: NovaBone K101860 Inion BioRestore K090177 OsteoBiologics Inc. PolyGraft K033707 Synthes chronOS K013072… | 2009 |
| * | K033707 | Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX…Summary page 4…redicate Device: NovaBone K101860 Inion BioRestore K090177 OsteoBiologics Inc. PolyGraft K033707 Synthes chronOS K013072 IV. Device Description The Bio2 Technologies implants are bone… | 2004 |
| * | K013072 | Chronos Tricalcium Prosphate (Chronos TCP)Summary page 4…Inion BioRestore K090177 OsteoBiologics Inc. PolyGraft K033707 Synthes chronOS K013072 IV. Device Description The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151876 | Bio2 Fusion Implant System | 2015 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 31 ancestors has a recall of any class.
- Of its descendants, K151876 (Bio2 Technologies, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K101860.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
The Bio2 CLM+BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bio2 CLMsBG Bioactive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osscous defects or osseous defects created from traumatic injury to the bone.
The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
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/K142463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142463: Bio2 CLM BG Bioactive Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142463
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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