510(k) · Cleared
ClearedA-Grix Resorbable Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ag Digital Technology Corp. · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 2, 2010 as substantially equivalent to K031319 (Aspine USA, Inc., 2003) after a 265-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Mar 2, 2010
- Review
- 265 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963587 (1997). 9 ancestors in all, the oldest K960978 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
- 2 generations backK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
- 1 generation backK031319 Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003
- This deviceK091688 A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010
- Descendant · cites it directly · 0 of its ownK121453 A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013
Most influential descendants
Showing 1 of 1 · See all- K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) | Wrightmedicaltechnologyinc | 1997 | — |
| −2 | K991854 | Osteoplast, Model POP200 | Interpore Cross Intl. | 1999 | — |
| −1 | K031319 | Osteo-G Bone Void Filler System | Aspine USA, Inc. | 2003 | — |
| 0 (this device) | K091688 | A-Grix Resorbable Bone Void Filler | Ag Digital Technology Corp. | 2010 | — |
| +1 | K121453 | A-Grix TE Resorable Bone Void Filler | Ag Digital Technology Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K031319 | Osteo-G Bone Void Filler SystemSummary page 1…Regulation Number: 21CFR 888.3045 4. Predicate Device: The predicate device is the *Osteo-G bone void filler (K031319) marketed by ASPINE USA, INC. 5. Device Description: The A-GRIX Resorbable Bone Void Filler cont… | 2003 |
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 |
|---|---|---|---|
| K121453 | A-Grix TE Resorable Bone Void Filler | 2013 | 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 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K121453 (Ag Digital Technology Corp., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031319.
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. 2010, 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?
A-GRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091688 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091688: A-Grix Resorbable Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091688
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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