510(k) · Cleared
ClearedAccell TBM-R
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 Sep 24, 2008 as substantially equivalent to K061880 (Isotis NV, 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Sep 24, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K040980 (2004). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK061880 Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV · 2007
- This deviceK081817 Accell TBM-RIsotis Orthobiologics, Inc. · 2008
View 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 | K061880 | Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC | Isotis NV | 2007 | — |
| 0 (this device) | K081817 | Accell TBM-R | Isotis Orthobiologics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 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? (2)
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…id filler 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), and Grafton DBM- Flex… | 2007 |
| * | K051195 | Grafton DBMSummary page 1…VICES: Accell Family of Products K061880 (Accell DBM100, Accell TBM, Accell A2i and Accell Connexus), and Grafton DBM- Flex K051195 5.1 Substantially Equivalence: The Accell TBM-R is substantially equivalent in intended use, principal of operation and techno… | 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 4 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 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. 2008, 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 TBM-R is 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, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). 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/K081817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081817: Accell TBM-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081817
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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