510(k) · Cleared
ClearedConfirm Bioactive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 26, 2014 as substantially equivalent to K130392 (Globus Medical, Inc., 2013) and 3 other predicates after a 270-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Aug 26, 2014
- Review
- 270 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K960978 (1996). 56 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations between
- 3 generations backK093447 CarrigenEtex Corp. · 2010
- 2 generations backK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- 1 generation backK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- This deviceK133678 Confirm BioactiveGlobus Medical, Inc. · 2014
Show all 11 generations
- Root · 11 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 10 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 9 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 8 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 7 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 6 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 5 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 4 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 3 generations backK093447 CarrigenEtex Corp. · 2010
- 2 generations backK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- 1 generation backK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- This deviceK133678 Confirm BioactiveGlobus Medical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −10 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −9 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −8 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −7 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −6 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −5 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −4 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −3 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| −2 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| −1 | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K133678 | Confirm Bioactive | Globus Medical, Inc. | 2014 | — |
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 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K130392 | Kinex BioactiveSummary page 5…Device Product Codes: MQV Regulatory Class: II, Panel Code 87 Predicate(s): KINEX™ Bioactive Bone Void Filler, K130392 Vitoss® BA Bioactive Bone Graft Substitute, K103173 & K994337… | 2013 |
| * | K103173 | Vitoss BA Bimodal Bioactive Bone Graft SubstituteSummary page 5…Regulatory Class: II, Panel Code 87 Predicate(s): KINEX™ Bioactive Bone Void Filler, K130392 Vitoss® BA Bioactive Bone Graft Substitute, K103173 & K994337 NovaBone® Bioactive Bone Graft, K080009 Purpose: The purpose of this su… | 2011 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 5…e 87 Predicate(s): KINEX™ Bioactive Bone Void Filler, K130392 Vitoss® BA Bioactive Bone Graft Substitute, K103173 & K994337 NovaBone® Bioactive Bone Graft, K080009 Purpose: The purpose of this submission is to request clearance of t… | 2000 |
| * | K080009 | Novabone Putty- Bioactive Synthetic GraftSummary page 5…K130392 Vitoss® BA Bioactive Bone Graft Substitute, K103173 & K994337 NovaBone® Bioactive Bone Graft, K080009 Purpose: The purpose of this submission is to request clearance of the CONFIRM™ Bioactive. Device Description: CONFIRM™ Bioacti… | 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 18 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 56 ancestors have a recall of any class.
- 2 other devices also cite its predicate K130392.
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?
CONFIRM™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. CONFIRM™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) and must be combined with bone marrow aspirate…
Read the full statement (133 words)
CONFIRM™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. CONFIRM™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ Putty, Plus Putty, Gel, Plus Gel, and Plus Crunch are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133678: Confirm Bioactive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133678
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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