510(k) · Cleared
ClearedKinex 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 15, 2013 as substantially equivalent to K103173 (Orthovita, Inc., 2011) and 3 other predicates after a 181-day review. Its family tree reaches back 10 generations to 1996. 8 later devices descend from it.
- Decided
- Aug 15, 2013
- Review
- 181 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K960978 (1996). 55 ancestors in all, the oldest K852682 (1985). 8 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 2 generations backK093447 CarrigenEtex Corp. · 2010
- 1 generation backK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- This deviceK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK190956 SCS 17-01Anika Therapeutics, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK223915 TactosetAnika Therapeutics, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK130977 Signify BioactiveGlobus Medical, Inc. · 2013
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 7 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 6 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 5 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 4 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 3 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 2 generations backK093447 CarrigenEtex Corp. · 2010
- 1 generation backK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- This deviceK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · cites it directly4descendants
- K190956SCS 17-01Anika Therapeutics, Inc. · 2020 · 2 generations on3descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 2 generations on2descendants
- K223915TactosetAnika Therapeutics, Inc. · 2023 · 2 generations on1descendant
- K130977Signify BioactiveGlobus Medical, Inc. · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −7 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −6 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −5 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −4 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −3 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −2 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| −1 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| 0 (this device) | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
| +1 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
| +2 | K190956 | SCS 17-01 | Anika Therapeutics, Inc. | 2020 | — |
| +2 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +2 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
| +1 | K130977 | Signify Bioactive | Globus Medical, Inc. | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K103173 | Vitoss BA Bimodal Bioactive Bone Graft SubstituteSummary page 1…Calcium Salt Bone Void Filler Product Codes: MQV Regulatory Class: 11,Panel Code 87 Predicate(s): Vitoss® BA Bioactive BGS K1 031 73 & K994337 NovaBone® Bloactive Bone Graft K080009 lnQu® (Bone Void Filler) K1 03799 Purpo… | 2011 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…Bone Void Filler Product Codes: MQV Regulatory Class: 11,Panel Code 87 Predicate(s): Vitoss® BA Bioactive BGS K1 031 73 & K994337 NovaBone® Bloactive Bone Graft K080009 lnQu® (Bone Void Filler) K1 03799 Purpose: The pu… | 2000 |
| * | K080009 | Novabone Putty- Bioactive Synthetic GraftSummary page 1…Regulatory Class: 11,Panel Code 87 Predicate(s): Vitoss® BA Bioactive BGS K1 031 73 & K994337 NovaBone® Bloactive Bone Graft K080009 lnQu® (Bone Void Filler) K1 03799 Purpose: The purpose of this submission is to request clearance of the KIN… | 2008 |
| * | K103799 | Inqu Paste Mix PlusSummary page 1…Predicate(s): Vitoss® BA Bioactive BGS K1 031 73 & K994337 NovaBone® Bloactive Bone Graft K080009 lnQu® (Bone Void Filler) K1 03799 Purpose: The purpose of this submission is to request clearance of the KINEXTM Bioactive. Device Description: KINEXTM Bioactive… | 2011 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.9 years on median.
- 5 of the 55 ancestors have a recall of any class.
- Of its descendants, K173008 (Anika Therapeutics, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K103173.
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?
KINEXTM 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. KINEXTM Plus Putty and KINEXTM Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone…
Read the full statement (132 words)
KINEXTM 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. KINEXTM Plus Putty and KINEXTM Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX TM Strip, KINEX TM Plus Strip, KINEX TM Putty and KINEX TM Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEXTM resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130392: Kinex Bioactive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130392
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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