510(k) · Cleared
Recalled · Class II · 2014Accell EVO3C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis Orthobiologics, Inc. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Aug 10, 2009 as substantially equivalent to K061880 (Isotis NV, 2007) and 4 other predicates after a 109-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 10, 2009
- Review
- 109 days
- Class
- Class II
- Product code
- MBP
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to K040980 (2004). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 2 generations backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- 1 generation backK050642 Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
- This deviceK091193 Accell EVO3CIsotis Orthobiologics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK212135 Dry DBM- A PuttySeaspine Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK231030 Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2023
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 |
|---|---|---|---|---|---|
| −3 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −2 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| −1 | K050642 | Orthoblast II Putty and Paste | Isotis Orthobiologics, Inc. | 2005 | — |
| 0 (this device) | K091193 | Accell EVO3C | Isotis Orthobiologics, Inc. | 2009 | — |
| +1 | K212135 | Dry DBM- A Putty | Seaspine Corporation | 2021 | — |
| +2 | 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 |
|---|---|---|
| 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 MBP? 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 MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K061880 | Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCSummary page 1…NAME: DEVICE Class II CLASSIFICATION: PRODUCT CODE MQV, MBP PREDICATE DEVICES: Accell Family of products - K061880 (Accell DBM100, Accell TBM®, Accell A2i and Accell Connexus®), DYNAGR… | 2007 |
| * | K040419 | Dynagraft IISummary page 1…l Family of products - K061880 (Accell DBM100, Accell TBM®, Accell A2i and Accell Connexus®), DYNAGRAFT® II - K040419, ORTHOBLAST® II - K050642, DBX DBM Mix - K063676, Grafton DBM Orthobl… | 2005 |
| * | K050642 | Orthoblast II Putty and PasteSummary page 1…Accell TBM®, Accell A2i and Accell Connexus®), DYNAGRAFT® II - K040419, ORTHOBLAST® II - K050642, DBX DBM Mix - K063676, Grafton DBM Orthoblend - K051195 5.1 Substantially Equi… | 2005 |
| * | K063676 | DBX Demineralized Bone Matrix MixSummary page 1…cell TBM®, Accell A2i and Accell Connexus®), DYNAGRAFT® II - K040419, ORTHOBLAST® II - K050642, DBX DBM Mix - K063676, Grafton DBM Orthoblend - K051195 5.1 Substantially Equivalent To: The Accell E… | 2007 |
| * | K051195 | Grafton DBMSummary page 1…DYNAGRAFT® II - K040419, ORTHOBLAST® II - K050642, DBX DBM Mix - K063676, Grafton DBM Orthoblend - K051195 5.1 Substantially Equivalent To: The Accell Evo3cTI is substantially equivalent in intended use, principal of… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212135 | Dry DBM- A Putty | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2014 | Class II | Z-1868-2014 | Packaging | This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K212135 (Seaspine Corporation, 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K061880.
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, 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 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Accell Evo3c TM is intended for filling voids and gaps in.the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler 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/K091193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091193: Accell EVO3C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091193
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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