510(k) · Cleared
ClearedAccell Connexus Demineralized Bone Matrix Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis NV · NUN Bone Grafting Material, Human Source
Cleared on Mar 27, 2006 as substantially equivalent to K043573 (Isotis Orthobiologics, Inc., 2005) after a 48-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.
- Decided
- Mar 27, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960267 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960267 TBM SpongeBiocoll Laboratories, Inc. · 1996
- 1 generation backK043573 Dynagraft II DentalIsotis Orthobiologics, Inc. · 2005
- This deviceK060306 Accell Connexus Demineralized Bone Matrix PuttyIsotis NV · 2006
- Descendant · cites it directly · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- Descendant · 2 generations on · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960267 | TBM Sponge | Biocoll Laboratories, Inc. | 1996 | — |
| −1 | K043573 | Dynagraft II Dental | Isotis Orthobiologics, Inc. | 2005 | — |
| 0 (this device) | K060306 | Accell Connexus Demineralized Bone Matrix Putty | Isotis NV | 2006 | — |
| +1 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +2 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +2 | K082463 | Progenix | Medtronic Sofamor Danek | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 NUN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K043573 | Dynagraft II DentalSummary page 1…Graft Material Regulatory Class: II Product Code: NUN 3. PREDICATE DEVICE DynaGraft II Dental (Demineralized Bone Matrix) [K043573] 4. DEVICE DESCRIPTION Accell Connexus' DBM Putty is derived from selected donated human bone tissue that… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080462 | Progenix DBM Putty | 2008 | 2 |
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 10 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080462 (Medtronic Sofamor Danek, 2008) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K043573.
How does its category compare?
All NUN devicesNUN Bone Grafting Material, Human Source: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NUN
75in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUN
No recall names NUN since 2007.
Adverse event reports per year · NUN
6in 2025
MAUDE reports naming product code NUN, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 75 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 25 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Accell Connexus' DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
- Filling of defects after root resection, apicoectomy and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Treatment of periodontal defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060306: Accell Connexus Demineralized Bone Matrix Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060306
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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