510(k) · Cleared
ClearedInqu Paste Mix Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isto Technologies, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 29, 2011 as substantially equivalent to K063359 (Isto Technologies, Inc., 2007) and 2 other predicates after a 244-day review. Its family tree reaches back 9 generations to 1996. 9 later devices descend from it.
- Decided
- Aug 29, 2011
- Review
- 244 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K960978 (1996). 42 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations between
- 3 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 2 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 1 generation backK093447 CarrigenEtex Corp. · 2010
- This deviceK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK190956 SCS 17-01Anika Therapeutics, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK223915 TactosetAnika Therapeutics, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 7 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 6 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 5 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 4 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 3 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 2 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 1 generation backK093447 CarrigenEtex Corp. · 2010
- This deviceK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130392Kinex BioactiveGlobus Medical, Inc. · 2013 · cites it directly8descendants
- K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · 2 generations on4descendants
- K190956SCS 17-01Anika Therapeutics, Inc. · 2020 · 3 generations on3descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 3 generations on2descendants
- K223915TactosetAnika Therapeutics, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −8 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −7 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −6 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −5 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −4 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −3 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −2 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −1 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| 0 (this device) | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| +1 | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
| +2 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
| +3 | K190956 | SCS 17-01 | Anika Therapeutics, Inc. | 2020 | — |
| +3 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +3 | K223915 | Tactoset | Anika Therapeutics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K063359 | INQUSummary page 1…ler, bone void, calcium salt compound Classification Number: 21 CFR 888.3045 Product Code: MQV Predicate Devices: lnQu®', ISTO Technologies, Inc., K063359 lnQu 0' ISTO Technologies, Inc., K071428 CarriGen Porous Bone Substitute, ETE… | 2007 |
| * | K071428 | INQUSummary page 1…CFR 888.3045 Product Code: MQV Predicate Devices: lnQu®', ISTO Technologies, Inc., K063359 lnQu 0' ISTO Technologies, Inc., K071428 CarriGen Porous Bone Substitute, ETEX Corp., K093447 Statement of lnQu 0 is a resorbable… | 2007 |
| * | K093447 | CarrigenSummary page 1…STO Technologies, Inc., K063359 lnQu 0' ISTO Technologies, Inc., K071428 CarriGen Porous Bone Substitute, ETEX Corp., K093447 Statement of lnQu 0 is a resorbable bone void filler intended to fill bony gaps or Intended Use: voids… | 2010 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130392 | Kinex Bioactive | 2013 | 8 |
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 15 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 42 ancestors have a recall of any class.
- Of its descendants, K130392 (Globus Medical, Inc., 2013) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K063359.
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. 2011, 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?
lnQu® is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. lnQu® is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu® is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created osseous 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 as stated in the FDA summary.
https://510kreport.com/device/K103799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103799: Inqu Paste Mix Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103799
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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