510(k) · Cleared
ClearedMiig II Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 4, 2003 after a 67-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.
- Decided
- Mar 4, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 7 citing it directly.
- This deviceK024336 Miig II Bone Graft SubstituteWrightmedicaltechnologyinc · 2003
- Descendant · cites it directly · 30 of its ownK060061 Stryker Injectable CementStryker Corp. · 2006
- Descendant · 2 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
- Descendant · cites it directly · 10 of its ownK051951 Cerament Bone Void FillerBonesupport AB · 2005
- Descendant · 2 generations on · 8 of its ownK060763 Stryker Injectable CementStryker · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK073316 Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K060061Stryker Injectable CementStryker Corp. · 2006 · cites it directly30descendants
- K161447HydroSet XTOrthovita, Inc. · 2016 · 2 generations on10descendants
- K051951Cerament Bone Void FillerBonesupport AB · 2005 · cites it directly10descendants
- K060763Stryker Injectable CementStryker · 2006 · 2 generations on8descendants
- K073316Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024336 | Miig II Bone Graft Substitute | Wrightmedicaltechnologyinc | 2003 | — |
| +1 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| +2 | K161447 | HydroSet XT | Orthovita, Inc. | 2016 | 2 |
| +1 | K051951 | Cerament Bone Void Filler | Bonesupport AB | 2005 | — |
| +2 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
| +2 | K073316 | Cerament Bone Void Filler, Model A0210 | Bonesupport AB | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | — | MIIG Named without a submission number |
What descends from it? (47)
See all 477 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060061 | Stryker Injectable Cement | 2006 | 30 |
| K051951 | Cerament Bone Void Filler | 2005 | 10 |
| K051603 | Stryker Injectable Cement | 2005 | 3 |
| K051406 | Osteocure Resorbable Bead Kit | 2005 | 3 |
| K073303 | Norian Drillable | 2008 | 1 |
| K032286 | Calcigen Psi Bone Graft Substitute | 2003 | 1 |
| K070864 | Boneplast QS Calcium Sulfate Bone Void Filler | 2007 | 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?
- Of its descendants, K060061 (Stryker Corp., 2006) has gone furthest, with 30 descendants of its own.
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.
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?
The MTIGTMpaste is intended to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system @e., the extremities, spine, and pelvis) and to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIGTMpaste provides a bone void filler that resorbs and is replaced with bone during the healing process. The…
Read the full statement (129 words)
The MTIGTMpaste is intended to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system @e., the extremities, spine, and pelvis) and to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIGTMpaste provides a bone void filler that resorbs and is replaced with bone during the healing process.
The MIIGTMpaste cured in situ provides an open voidgap filler that can augment provisional hardware (e.g., K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provjde structural support during the healing process.
The MIIGTMis provided sterile for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024336 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024336: Miig II Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024336
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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