510(k) · Cleared
Recalled · Class II · 2026Resorbable Mesh Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 16, 2017 as substantially equivalent to K123691 (Medtronic Sofamor Danek, Inc., 2013) and 2 other predicates after a 125-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 16, 2017
- Review
- 125 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K051195 (2005). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK051195 Grafton DBMOsteotech, Inc. · 2005 · Recalled
- 1 generation backK123691 Magnifuse Bone Graft (Cleared as Grafton II Edbm)Medtronic Sofamor Danek, Inc. · 2013
- This deviceK172130 Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 0 of its ownK200290 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation · 2020
- Descendant · cites it directly · 0 of its ownK193040 Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051195 | Grafton DBM | Osteotech, Inc. | 2005 | 30 |
| −1 | K123691 | Magnifuse Bone Graft (Cleared as Grafton II Edbm) | Medtronic Sofamor Danek, Inc. | 2013 | — |
| 0 (this device) | K172130 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | SeaSpine Orthopedics Corporation | 2020 | — |
| +1 | K193040 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K123691 | Magnifuse Bone Graft (Cleared as Grafton II Edbm)Summary page 4…e Manufacturer Number PRIMARY PREDICATE Device MAGNIFUSE Bone Medtronic Sofamor K123691 MQV, MBP Graft Danek, Inc. Additional PREDICATE Devices… | 2013 |
| * | K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone…Summary page 4…Medtronic Sofamor K123691 MQV, MBP Graft Danek, Inc. Additional PREDICATE Devices K082615 MQV GRAFTON II eDBM OsteoTech, Inc. MAGNIFUSE II Bone… | 2008 |
| * | K122513 | Cleared Under Grafton II EdbmSummary page 4…15 MQV GRAFTON II eDBM OsteoTech, Inc. MAGNIFUSE II Bone Medtronic Sofamor K122513 MQV, MBP Graft Danek, Inc. Device Description The Resor… | 2013 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2026 | Class II | Z-2820-2026 | Process control | Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K200290 (SeaSpine Orthopedics Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123691.
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. 2017, 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?
The Resorbable Mesh Device is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. The Resorbable Mesh Device is resorbed/remodeled and replaced by host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172130: Resorbable Mesh Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172130
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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