510(k) · Cleared
ClearedResorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
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 May 11, 2020 as substantially equivalent to K172130 (SeaSpine Orthopedics Corporation, 2017) after a 96-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- May 11, 2020
- Review
- 96 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K051195 (2005). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK051195 Grafton DBMOsteotech, Inc. · 2005 · Recalled
- 2 generations backK123691 Magnifuse Bone Graft (Cleared as Grafton II Edbm)Medtronic Sofamor Danek, Inc. · 2013
- 1 generation backK172130 Resorbable Mesh DeviceSeaSpine Orthopedics Corporation · 2017 · Recalled
- This deviceK200290 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051195 | Grafton DBM | Osteotech, Inc. | 2005 | 30 |
| −2 | K123691 | Magnifuse Bone Graft (Cleared as Grafton II Edbm) | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −1 | K172130 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | 2017 | 1 |
| 0 (this device) | K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | SeaSpine Orthopedics Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K172130 | Resorbable Mesh DeviceSummary page 4…mber Product Code Trade Name Manufacturer PRIMARY PREDICATE Device Resorbable Mesh K172130 MQV Device IsoTis OrthoBiologics, Inc. (Ballast… | 2017 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K172130.
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. 2020, 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 Pouch, once filled with autograft, 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 in the posterolateral spine and pelvis as a bone void filler and bone graft extender. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Ultimately, the Resorbable Mesh Pouch will be resorbed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200290: Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200290
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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