510(k) · Cleared
ClearedAdaptos®Fuse Bone Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomendex OY · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 17, 2026 as substantially equivalent to K240404 (Novabone Products, LLC, 2024) and 2 other predicates after a 96-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Feb 17, 2026
- Review
- 96 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K960978 (1996). 29 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 2 generations backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK240404 NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610…Novabone Products, LLC · 2024
- This deviceK253524 Adaptos®Fuse Bone GraftBiomendex OY · 2026
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 7 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 6 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 5 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 4 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 3 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 2 generations backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK240404 NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610…Novabone Products, LLC · 2024
- This deviceK253524 Adaptos®Fuse Bone GraftBiomendex OY · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −7 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −6 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −5 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −4 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −3 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −2 | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −1 | K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | Novabone Products, LLC | 2024 | — |
| 0 (this device) | K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Summary page 5…ct Code MQV Panel Orthopedic Predicates Primary Predicate NovaBone Putty – Bioactive Synthetic Bone Graft (K240404) Additoinal Predicates Synthes chronOS and chronOS Composite (K071046, K043045) NuVas… | 2024 |
| * | K071046 | Synthes Chronos CompositeSummary page 5…icates Primary Predicate NovaBone Putty – Bioactive Synthetic Bone Graft (K240404) Additoinal Predicates Synthes chronOS and chronOS Composite (K071046, K043045) NuVasive Attrax Putty (K203714) FIBERGRAFT® BG Putty… | 2007 |
| * | K043045 | Synthes (Usa) ChronosSummary page 5…imary Predicate NovaBone Putty – Bioactive Synthetic Bone Graft (K240404) Additoinal Predicates Synthes chronOS and chronOS Composite (K071046, K043045) NuVasive Attrax Putty (K203714) FIBERGRAFT® BG Putty (K222276)… | 2005 |
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 30 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 29 ancestors has a recall of any class.
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. 2026, 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?
Adaptos®Fuse Bone Graft is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone (i.e., posterolateral spine, intervertebral disc space, and pelvis). In interbody fusion procedures, Adaptos®Fuse Bone Graft must be used with interbody fusion devices FDA cleared for use with bone void filler. Adaptos®Fuse Bone Graft Granules must be mixed with autograft prior to use. Following placement in the bony void or gap, Adaptos®Fuse Bone Graft are resorbed and replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253524 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253524: Adaptos®Fuse Bone Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253524
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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