510(k) · Cleared
ClearedMiig SR
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 Feb 27, 2006 after a 55-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Feb 27, 2006
- Review
- 55 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK060011 Miig SRWrightmedicaltechnologyinc · 2006
- Descendant · cites it directly · 15 of its ownK070437 Pro-Dense Bone Void FillerWrightmedicaltechnologyinc · 2007
- Descendant · 2 generations on · 11 of its ownK113871 Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc · 2013
- Descendant · 2 generations on · 10 of its ownK072597 Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc · 2007
- Descendant · 3 generations on · 7 of its ownK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
- Descendant · 4 generations on · 5 of its ownK182823 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K070437Pro-Dense Bone Void FillerWrightmedicaltechnologyinc · 2007 · cites it directly15descendants
- K113871Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc · 2013 · 2 generations on11descendants
- K072597Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc · 2007 · 2 generations on10descendants
- K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 3 generations on7descendants
- K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060011 | Miig SR | Wrightmedicaltechnologyinc | 2006 | — |
| +1 | K070437 | Pro-Dense Bone Void Filler | Wrightmedicaltechnologyinc | 2007 | — |
| +2 | K113871 | Pro-Dense Bone Graft Substitute | Wrightmedicaltechnologyinc | 2013 | — |
| +2 | K072597 | Pro-Dense Core Decompression Procedure Kit | Wrightmedicaltechnologyinc | 2007 | — |
| +3 | K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
| +4 | K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | Wright Medical Technology bone void fillers Named without a submission number |
What descends from it? (16)
See all 162 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?
- Of its descendants, K070437 (Wrightmedicaltechnologyinc, 2007) has gone furthest, with 15 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 intended use for the MIIG® SR resultant paste is to be injected, digitally packed into open bone voids/gaps to cure in-situ, or molded into solid pellets that are gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.…
Read the full statement (152 words)
The intended use for the MIIG® SR resultant paste is to be injected, digitally packed into open bone voids/gaps to cure in-situ, or molded into solid pellets that are gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
The MIIG® SR paste cured in situ provides an open void/gap 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 provide structural support during the healing process.
MIIG® SR is provided sterile for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060011 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060011: Miig SR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060011
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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