510(k) · Cleared
ClearedAcceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis NV · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 15, 2007 as substantially equivalent to K040419 (Isotis Orthobiologics, Inc., 2005) and 3 other predicates after a 408-day review. Its family tree reaches back 2 generations to 2004. 5 later devices descend from it.
- Decided
- Aug 15, 2007
- Review
- 408 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K040980 (2004). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 1 generation backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- This deviceK061880 Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV · 2007
- Descendant · cites it directly · 2 of its ownK091193 Accell EVO3CIsotis Orthobiologics, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK212135 Dry DBM- A PuttySeaspine Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK231030 Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2023
- Descendant · cites it directly · 0 of its ownK103742 Accell EVO3 (Formerly Accell A2I)Integra Life Sciences · 2011
- Descendant · cites it directly · 0 of its ownK081817 Accell TBM-RIsotis Orthobiologics, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K091193Accell EVO3CIsotis Orthobiologics, Inc. · 2009 · cites it directly2descendants
- K212135Dry DBM- A PuttySeaspine Corporation · 2021 · 2 generations on1descendant
- K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2023 · 3 generations on0descendants
- K103742Accell EVO3 (Formerly Accell A2I)Integra Life Sciences · 2011 · cites it directly0descendants
- K081817Accell TBM-RIsotis Orthobiologics, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −1 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| 0 (this device) | K061880 | Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC | Isotis NV | 2007 | — |
| +1 | K091193 | Accell EVO3C | Isotis Orthobiologics, Inc. | 2009 | 1 |
| +2 | K212135 | Dry DBM- A Putty | Seaspine Corporation | 2021 | — |
| +3 | K231030 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | 2023 | — |
| +1 | K103742 | Accell EVO3 (Formerly Accell A2I) | Integra Life Sciences | 2011 | — |
| +1 | K081817 | Accell TBM-R | Isotis Orthobiologics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K040419 | Dynagraft IISummary page 1….F.R. § 888.3045 Resorbable calcium salt bone void filler device PREDICATE DEVICES DynaGraft II Paste and Putty (K040419) AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K0… | 2005 |
| * | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold…Summary page 1…DynaGraft II Paste and Putty (K040419) AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with… | 2004 |
| * | K031399 | Intergro DBMSummary page 1…ix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with inert carrier Porcine Collagen (K043420) INTENDE… | 2005 |
| * | K043420 | Osteofil, Optefil, Regenafil, Rti Allograft PasteSummary page 1…InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with inert carrier Porcine Collagen (K043420) INTENDED USE/INDICATIONS The Accell Family of products are intended for filling voids and gaps in the skeletal system… | 2005 |
| † | K050690 | Connexus | 2005 |
| † | K052098 | Connexus, .5CC, Model 023000-005 | 2005 |
What descends from it? (5)
3 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K091193 (Isotis Orthobiologics, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K040419.
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. 2007, 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 Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061880: Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061880
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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