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. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Dec 16, 2005 after a 220-day review. The FDA summary names no predicate by number. 140 later devices descend from it. It has been recalled 30 times.
- Decided
- Dec 16, 2005
- Review
- 220 days
- Class
- Class II
- Product code
- MBP
- Recalls
- 30
- Predicates
- 0
140 later devices descend from it, 11 citing it directly.
- This deviceK051195 Grafton DBMOsteotech, Inc. · 2005
- Descendant · cites it directly · 120 of its ownK060728 Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006
- Descendant · 2 generations on · 71 of its ownK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- Descendant · 2 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- Descendant · 2 generations on · 51 of its ownK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- Descendant · 3 generations on · 50 of its ownK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
Showing 5 of 140 descendants. See all descendants
Descendants cleared per year
2006high 14 (2025) · low 2 (2006)2026
Most influential descendants
Showing 5 of 140 · See all- K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006 · cites it directly120descendants
- K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008 · 2 generations on71descendants
- K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 2 generations on59descendants
- K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007 · 2 generations on51descendants
- K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008 · 3 generations on50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051195 | Grafton DBM | Osteotech, Inc. | 2005 | — |
| +1 | K060728 | Novabone Putty - Bioactive Synthetic Graft | Novabone Products, LLC | 2006 | — |
| +2 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| +2 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| +2 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| +3 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 9 | 0 |
| 2010 | 6 | 0 |
| 2011 | 11 | 0 |
| 2012 | 2 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 7 | 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?
The FDA summary names no predicate by number.
What descends from it? (140)
See all 14011 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060728 | Novabone Putty - Bioactive Synthetic Graft | 2006 | 120 |
| K123691 | Magnifuse Bone Graft (Cleared as Grafton II Edbm) | 2013 | 5 |
| K091321 | Osteoselect Demineralized Bone Matrix Putty | 2009 | 2 |
| K091193 | Accell EVO3C | 2009 | 2 |
| K063549 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | 2007 | 2 |
| K061668 | Optecure +CCC | 2006 | 2 |
| K180121 | Rafugen DBM | 2018 | 0 |
| K103742 | Accell EVO3 (Formerly Accell A2I) | 2011 | 0 |
| K082002 | Progenix Plus | 2008 | 0 |
| K081817 | Accell TBM-R | 2008 | 0 |
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… |
| Sep 26, 2023 | Class II | Z-0161-2024 | Employee error | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with… |
| Sep 26, 2023 | Class II | Z-0163-2024 | Employee error | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with… |
| Sep 26, 2023 | Class II | Z-0164-2024 | Employee error | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with… |
| Sep 26, 2023 | Class II | Z-0165-2024 | Employee error | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with… |
| Sep 26, 2023 | Class II | Z-0166-2024 | Employee error | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with… |
| Sep 26, 2023 | Class II | Z-0167-2024 | Employee error | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with… |
| Sep 26, 2023 | Class II | Z-0162-2024 | Employee error | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with… |
| Feb 8, 2023 | Class II | Z-1324-2023 | Process control | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| Feb 8, 2023 | Class II | Z-1325-2023 | Process control | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| Feb 8, 2023 | Class II | Z-1327-2023 | Process control | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| Feb 8, 2023 | Class II | Z-1333-2023 | Process control | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| Feb 8, 2023 | Class II | Z-1326-2023 | Process control | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| Feb 8, 2023 | Class II | Z-1328-2023 | Process control | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| Feb 8, 2023 | Class II | Z-1323-2023 | Process control | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
| 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. |
| Aug 8, 2011 | Not classified | Z-0416-2012 | Material/Component Contamination | Aseptic conditions during the production of these products may have been compromised. |
| Aug 8, 2011 | Not classified | Z-0415-2012 | Material/Component Contamination | Aseptic conditions during the production of these products may have been compromised. |
The 5 latest of 30 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060728 (Novabone Products, LLC, 2006) has gone furthest, with 120 descendants of its own.
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.
FDA decisions per year · MBP
1in 2024
2007high 5 (2007) · low 0 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
2007high 188 (2007) · low 93 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
2007high 13 (2012) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
2007high 24 (2012) · low 1 (2024)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?
GRAFTON® DBM is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051195: 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/K051195
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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