510(k) · Cleared
Recalled · Class II · 2026Grafton Plus DBM Paste
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 Nov 23, 2005 as substantially equivalent to K020078 (Exactech, Inc., 2004) and 3 other predicates after a 384-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it. It has been recalled 15 times.
- Decided
- Nov 23, 2005
- Review
- 384 days
- Class
- Class II
- Product code
- MBP
- Recalls
- 15
- Predicates
- 4
Its longest line of descent runs back 3 generations to K963562 (1997). 7 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 2 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 1 generation backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
- This deviceK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005
- Descendant · cites it directly · 9 of its ownK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
- Descendant · 2 generations on · 4 of its ownK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
- Descendant · 2 generations on · 3 of its ownK132868 CarricellEtex Corporation · 2015
- Descendant · 3 generations on · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006 · cites it directly9descendants
- K072265Progenix DMB PuttyMedtronic Sofamor Danek · 2008 · 2 generations on4descendants
- K132868CarricellEtex Corporation · 2015 · 2 generations on3descendants
- K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017 · 3 generations on2descendants
- K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −2 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −1 | K040755 | Exactech Resorbable Room Temperature Bone Paste | Exactech, Inc. | 2004 | — |
| 0 (this device) | K043048 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | — |
| +1 | K060794 | Progenix DBM Putty and Paste | Medtronic Sofamor Danek | 2006 | — |
| +2 | K072265 | Progenix DMB Putty | Medtronic Sofamor Danek | 2008 | — |
| +2 | K132868 | Carricell | Etex Corporation | 2015 | — |
| +3 | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
| +2 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 5 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K020078 | Exactech Resorbable Bone PasteSummary page 1…g predicate devices. Trade/Pronrietary/Model Name Manufacturer 510Q(K)# Exactech Resorbable Bone Paste Exactech K020078 Exactech Resorbable Room Exactech K040755 Temperature Bone Paste AllomatrixPutty… | 2004 |
| * | K040755 | Exactech Resorbable Room Temperature Bone PasteSummary page 1…510Q(K)# Exactech Resorbable Bone Paste Exactech K020078 Exactech Resorbable Room Exactech K040755 Temperature Bone Paste AllomatrixPutty Wright Medical K020895 AllomatrixPutty… | 2004 |
| * | K020895 | Allomatrix Model# 86Summary page 1…ctech Resorbable Room Exactech K040755 Temperature Bone Paste AllomatrixPutty Wright Medical K020895 AllomatrixPutty Wright Medical K041186 4. Device Description: GRAFTON PLUS® DBM Paste… | 2004 |
| * | K041168 | Allomatrix Putty Our reading of the summary gave K041186, FDA’s number for CADDY (Afikim Electric Vehicles). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AllomatrixPutty”. | 2004 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060794 | Progenix DBM Putty and Paste | 2006 | 9 |
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-0137-2027 | 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-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… |
| Feb 8, 2023 | Class II | Z-1329-2023 | 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. |
| 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 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K060794 (Medtronic Sofamor Danek, 2006) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K020078.
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
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?
Grafton Plus® DBM Paste 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 Plus® DBM Paste 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/K043048 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043048: Grafton Plus DBM Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043048
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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