510(k) · Cleared
ClearedINQU
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 Apr 16, 2007 as substantially equivalent to K040047 (Osteobiologics, Inc., 2004) after a 160-day review. Its family tree reaches back 4 generations to 1996. 13 later devices descend from it.
- Decided
- Apr 16, 2007
- Review
- 160 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960978 (1996). 5 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK030288 Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
- 1 generation backK040047 Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc. · 2004 · Recalled
- This deviceK063359 INQUIsto Technologies, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK071428 INQUIsto Technologies, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK173008 SCS 17-01Anika Therapeutics, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK190956 SCS 17-01Anika Therapeutics, Inc. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K071428INQUIsto Technologies, Inc. · 2007 · cites it directly11descendants
- K103799Inqu Paste Mix PlusIsto Technologies, Inc. · 2011 · cites it directly9descendants
- K130392Kinex BioactiveGlobus Medical, Inc. · 2013 · 2 generations on8descendants
- K173008SCS 17-01Anika Therapeutics, Inc. · 2017 · 3 generations on4descendants
- K190956SCS 17-01Anika Therapeutics, Inc. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K030288 | Polygraft Bone Graft Substitute | Osteobiologics, Inc. | 2003 | — |
| −1 | K040047 | Polygraft BGS; Bone Graft Substitute | Osteobiologics, Inc. | 2004 | 1 |
| 0 (this device) | K063359 | INQU | Isto Technologies, Inc. | 2007 | — |
| +1 | K071428 | INQU | Isto Technologies, Inc. | 2007 | — |
| +1 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| +2 | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
| +3 | K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017 | — |
| +4 | K190956 | SCS 17-01 | Anika Therapeutics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K040047 | Polygraft BGS; Bone Graft SubstituteSummary page 1…ne void, calcium salt compound Classification Number: 21 CIFR 888.3045 Product Code: MQV Predicate Devices: PolyGraftrm BGS, OsteoBiologics, Inc., K040047 Statement of InQUTM is a resorbable bone void filler intended to fill bony gaps or Intended Use: voids… | 2004 |
What descends from it? (13)
See all 134 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 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K071428 (Isto Technologies, Inc., 2007) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K040047.
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. 2007, 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?
InQU TM is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQuTM is intended to be gently packed into bony gaps or voids in the skeletal system (extremities and pelvis). These defects may be surgically created or result from traumatic injury to the bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063359 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063359: INQU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063359
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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