510(k) · Cleared
ClearedProgenix DBM Putty and Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Dec 18, 2006 as substantially equivalent to K040262 (Musculoskeletal Transplant Foundation, 2005) and 3 other predicates after a 270-day review. Its family tree reaches back 4 generations to 1997. 9 later devices descend from it.
- Decided
- Dec 18, 2006
- Review
- 270 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K963562 (1997). 10 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 3 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 2 generations backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
- 1 generation backK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
- This deviceK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 4 of its ownK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 3 of its ownK132868 CarricellEtex Corporation · 2015
- Descendant · 2 generations on · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- Descendant · 3 generations on · 1 of its ownK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K072265Progenix DMB PuttyMedtronic Sofamor Danek · 2008 · cites it directly4descendants
- K132868CarricellEtex Corporation · 2015 · cites it directly3descendants
- K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017 · 2 generations on2descendants
- K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · cites it directly2descendants
- K242797OsteoFlo HydroFiberSurGenTec, LLC · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −3 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −2 | K040755 | Exactech Resorbable Room Temperature Bone Paste | Exactech, Inc. | 2004 | — |
| −1 | K043048 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | 15 |
| 0 (this device) | K060794 | Progenix DBM Putty and Paste | Medtronic Sofamor Danek | 2006 | — |
| +1 | K072265 | Progenix DMB Putty | Medtronic Sofamor Danek | 2008 | — |
| +1 | K132868 | Carricell | Etex Corporation | 2015 | — |
| +2 | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
| +1 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +3 | K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K040262 | DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixSummary page 2…substantially equivalent to previously cleared bone void fillers such as DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040262, SE 03/17/05), ALLOMATRIX® Putty (Wright Medical Technology, K041168, SE 08/02/04), GRAFTON PLUS® DBM Paste (Osteotech,… | 2005 |
| * | K041168 | Allomatrix PuttySummary page 2…h as DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040262, SE 03/17/05), ALLOMATRIX® Putty (Wright Medical Technology, K041168, SE 08/02/04), GRAFTON PLUS® DBM Paste (Osteotech, K040348, SE 11/23/05) and OSTEOFIL® DBM Paste (Regeneration Technologies,… | 2004 |
| * | K043048 | Grafton Plus DBM Paste Our reading of the summary gave K040348, FDA’s number for Modification to HNC-127-Int Neurovascular Array Coil (Mri Devices Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “GRAFTON PLUS® DBM Paste”. | 2005 |
| * | K043420 | Osteofil, Optefil, Regenafil, Rti Allograft PasteSummary page 2…Medical Technology, K041168, SE 08/02/04), GRAFTON PLUS® DBM Paste (Osteotech, K040348, SE 11/23/05) and OSTEOFIL® DBM Paste (Regeneration Technologies, Inc., K043420, SE 01/10/05). : DEPARTMENT OFHEALTH &HUMAN SERVICES Public Healt… | 2005 |
What descends from it? (9)
3 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)
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 9 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K072265 (Medtronic Sofamor Danek, 2008) has gone furthest, with 4 descendants of its own.
- 12 other devices also cite its predicate K040262.
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?
PROGENIXTM DBM Putty is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the pelvis, ilium and extremities not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIXTM DBM Putty provides a bone void filler that 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/K060794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060794: Progenix DBM Putty and Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060794
Report an extraction error
Are you the manufacturer?
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