510(k) · Cleared
ClearedDry DBM- A Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Oct 4, 2021 as substantially equivalent to K091193 (Isotis Orthobiologics, Inc., 2009) after an 88-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Oct 4, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040980 (2004). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 3 generations backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- 2 generations backK050642 Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
- 1 generation backK091193 Accell EVO3CIsotis Orthobiologics, Inc. · 2009 · Recalled
- This deviceK212135 Dry DBM- A PuttySeaspine Corporation · 2021
- Descendant · cites it directly · 0 of its ownK231030 Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −3 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| −2 | K050642 | Orthoblast II Putty and Paste | Isotis Orthobiologics, Inc. | 2005 | — |
| −1 | K091193 | Accell EVO3C | Isotis Orthobiologics, Inc. | 2009 | 1 |
| 0 (this device) | K212135 | Dry DBM- A Putty | Seaspine Corporation | 2021 | — |
| +1 | K231030 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K091193 | Accell EVO3CSummary page 4…3c 510(k) Number Product Code Trade Name Manufacturer PRIMARY PREDICATE Device K091193 MQV, MBP Accell Evo3c IsoTis OrthoBiologics, Inc.* *IsoTis OrthoBiologics, In… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231030 | Cove Putty, OsteoCove Putty | 2023 | 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K231030 (SeaSpine Orthopedics Corporation, 2023) has gone furthest, with 0 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. 2021, 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?
Dry DBM-A Putty 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
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/K212135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212135: Dry DBM- A Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212135
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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