510(k) · Cleared
ClearedSignify 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 Dec 24, 2013 as substantially equivalent to K130392 (Globus Medical, Inc., 2013) and 2 other predicates after a 259-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Dec 24, 2013
- Review
- 259 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). 1 later device descends from it, 1 citing it directly.
- 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 deviceK130977 Signify BioactiveGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK221737 InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc. · 2022
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 deviceK130977 Signify BioactiveGlobus Medical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc. · 2022 · cites it directly0descendants
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) | K130977 | Signify Bioactive | Globus Medical, Inc. | 2013 | — |
| +1 | K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | Globus Medical, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130392 | Kinex Bioactive Cleared while this submission was under review Summary page 1…Device Product Codes: MQV Regulatory Class: 11,Panel Code 87 Predicate(s): KINEX® Bicactive (K1 30392) Vitoss® BA Bioactive Bone Graft Substitute (KII031 73, K994337) Nova… | 2013 |
| Kept off the family tree | K110317 | Vitoss BA Bioactive Bone Graft Substitute Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…y Class: 11,Panel Code 87 Predicate(s): KINEX® Bicactive (K1 30392) Vitoss® BA Bioactive Bone Graft Substitute (KII031 73, K994337) NovaBone® Bioactive Bone Graft (K080009) Purpose: The purpose of this submission is to request clearance of… | 2000 |
| * | K080009 | Novabone Putty- Bioactive Synthetic GraftSummary page 1…ve (K1 30392) Vitoss® BA Bioactive Bone Graft Substitute (KII031 73, K994337) NovaBone® Bioactive Bone Graft (K080009) Purpose: The purpose of this submission is to request clearance of the SIGNIFYTM Bioactive. Device Description: SIGNIFYTM Bioa… | 2008 |
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 |
|---|---|---|---|
| K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | 2022 | 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 17 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.
- Of its descendants, K221737 (Globus Medical, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 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. 2013, 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?
SIGNIFY Bioactive is intended for use as a bone void filler 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.
SIGNIFY Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine).
SIGNIFY Putty and Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130977: Signify Bioactive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130977
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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