510(k) · Cleared
ClearedA-Grix TE Resorable 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 Feb 5, 2013 as substantially equivalent to K091688 (Ag Digital Technology Corp., 2010) after a 265-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Feb 5, 2013
- Review
- 265 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963587 (1997). 10 ancestors in all, the oldest K960978 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
- 3 generations backK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
- 2 generations backK031319 Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003
- 1 generation backK091688 A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010
- This deviceK121453 A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963587 | Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) | Wrightmedicaltechnologyinc | 1997 | — |
| −3 | K991854 | Osteoplast, Model POP200 | Interpore Cross Intl. | 1999 | — |
| −2 | K031319 | Osteo-G Bone Void Filler System | Aspine USA, Inc. | 2003 | — |
| −1 | K091688 | A-Grix Resorbable Bone Void Filler | Ag Digital Technology Corp. | 2010 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K091688 | A-Grix Resorbable Bone Void FillerSummary page 2…Conclusions: The A-GRIX TE Resorbable Bone Void Filler has the same intended use and technological characteristics as the A-GRIX Resorbable Bone Void Filler (K091688) marketed by AG DIGITAL Technology Corp.. Moreover, bench testing contained in this submission demonstrates that any differen… | 2010 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 10 ancestors has a recall.
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?
A-GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities 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 repl~ced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121453: A-Grix TE Resorable Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121453
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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