510(k) · Cleared
ClearedInqu Paste Mix
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 Sep 26, 2011 as substantially equivalent to K063359 (Isto Technologies, Inc., 2007) and 1 other predicate after an 89-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Sep 26, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K960978 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 4 generations backK030288 Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
- 3 generations backK040047 Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc. · 2004 · Recalled
- 2 generations backK063359 INQUIsto Technologies, Inc. · 2007
- 1 generation backK071428 INQUIsto Technologies, Inc. · 2007
- This deviceK111838 Inqu Paste MixIsto Technologies, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −5 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −4 | K030288 | Polygraft Bone Graft Substitute | Osteobiologics, Inc. | 2003 | — |
| −3 | K040047 | Polygraft BGS; Bone Graft Substitute | Osteobiologics, Inc. | 2004 | 1 |
| −2 | K063359 | INQU | Isto Technologies, Inc. | 2007 | — |
| −1 | K071428 | INQU | Isto Technologies, Inc. | 2007 | — |
| 0 (this device) | K111838 | Inqu Paste Mix | Isto Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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…iller, bone void, calcium salt compound Classification Number: 21 CER 888.3045 Product Code: MQV Predicate Devices: lnQu®0 ISTO Technologies, Inc., K063359 lnQu®' ISTO Technologies, Inc., K071428 Statement of lnQu®0 is a resorbable bone void fill… | 2007 |
| * | K071428 | INQUSummary page 1…21 CER 888.3045 Product Code: MQV Predicate Devices: lnQu®0 ISTO Technologies, Inc., K063359 lnQu®' ISTO Technologies, Inc., K071428 Statement of lnQu®0 is a resorbable bone void filler intended to fill bony gaps or Intended Use: voids t… | 2007 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 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®D 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111838: Inqu Paste Mix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111838
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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