510(k) · Cleared
Recalled · Class II · 2026Grafton DBM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteotech, Inc. · NUN Bone Grafting Material, Human Source
Cleared on Jan 3, 2006 after a 238-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 14 times.
- Decided
- Jan 3, 2006
- Review
- 238 days
- Class
- Class II
- Product code
- NUN
- Recalls
- 14
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK051188 Grafton DBMOsteotech, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK091729 Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009
- Descendant · cites it directly · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK130235 Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK100883 CarrigenEtex Corp. · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009 · cites it directly2descendants
- K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · cites it directly2descendants
- K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · cites it directly1descendant
- K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014 · cites it directly0descendants
- K100883CarrigenEtex Corp. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051188 | Grafton DBM | Osteotech, Inc. | 2006 | — |
| +1 | K091729 | Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone | Etex Corp. | 2009 | — |
| +1 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +1 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +1 | K130235 | Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty | Hans Biomed Corp. | 2014 | — |
| +2 | K100883 | Carrigen | Etex Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | — | human freeze dried bone, such as demineralized bone matrix Named without a submission number |
What descends from it? (7)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2026 | Class II | Z-0138-2027 | Process change control | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product… |
| Jan 6, 2014 | Class II | Z-0977-2014 | Packaging process control | Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm. |
| Apr 20, 2012 | Class II | Z-0084-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0087-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0088-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0091-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0092-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0093-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0083-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0089-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0090-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0085-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0086-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0094-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091729 (Etex Corp., 2009) has gone furthest, with 2 descendants of its own.
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?
GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts…
Read the full statement (136 words)
GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON®DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is absorbed/remodeled and replaced by host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051188: Grafton DBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051188
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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