510(k) Report

510(k) · Cleared

Cleared

Progenix DMB Putty

K072265510(k) TraditionalCleared Jan 9, 2008147-day reviewClass II21 CFR 888.3045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Sofamor Danek · MQV Filler, Bone Void, Calcium Compound

Cleared on Jan 9, 2008 as substantially equivalent to K060794 (Medtronic Sofamor Danek, 2006) and 4 other predicates after a 147-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.

Decided
Jan 9, 2008
Review
147 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K963562 (1997). 22 ancestors in all, the oldest K960978 (1996). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 5 other ancestors2004: 4 other ancestors2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2008: 4 descendants clearedK963562 · Wright Plaster of Paris Pellets · Wrightmedicaltechnologyinc · 1997×2: 2 generations cleared close together, K020078 (2004), K040755 (2004) K043048 · Grafton Plus DBM Paste · Osteotech, Inc. · 2005 · recalledK060794 · Progenix DBM Putty and Paste · Medtronic Sofamor Danek · 20061995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants K060794 · Progenix DBM Putty and Paste · Medtronic Sofamor Danek · 2006K043048 · Grafton Plus DBM Paste · Osteotech, Inc. · 2005 · recalledK040755 · Exactech Resorbable Room Temperature Bone Paste · Exactech, Inc. · 2004K020078 · Exactech Resorbable Bone Paste · Exactech, Inc. · 2004K963562 · Wright Plaster of Paris Pellets · Wrightmedicaltechnologyinc · 1997−50
  1. Root · 5 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
  2. 4 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
  3. 3 generations backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
  4. 2 generations backK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
  5. 1 generation backK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
  6. This deviceK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
  7. Descendant · cites it directly · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
  8. Descendant · 2 generations on · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
  9. Descendant · cites it directly · 0 of its ownK082002 Progenix PlusMedtronic Sofamor Danek · 2008
  10. Descendant · 2 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008

Most influential descendants

Showing 4 of 4 · See all
  • K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · cites it directly2descendants
  • K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · 2 generations on1descendant
  • K082002Progenix PlusMedtronic Sofamor Danek · 2008 · cites it directly0descendants
  • K082463ProgenixMedtronic Sofamor Danek · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K963562Wright Plaster of Paris PelletsWrightmedicaltechnologyinc1997—
−4K020078Exactech Resorbable Bone PasteExactech, Inc.2004—
−3K040755Exactech Resorbable Room Temperature Bone PasteExactech, Inc.2004—
−2K043048Grafton Plus DBM PasteOsteotech, Inc.200515
−1K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek2006—
0 (this device)K072265Progenix DMB PuttyMedtronic Sofamor Danek2008—
+1K080462Progenix DBM PuttyMedtronic Sofamor Danek2008—
+2K081950Progenix PlusMedtronic Sofamor Danek, Inc.2008—
+1K082002Progenix PlusMedtronic Sofamor Danek2008—
+2K082463ProgenixMedtronic Sofamor Danek2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200010
200120
200210
200310
200440
200550
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200840
FIG. 1 — Lineage of K072265, 1997–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MQV? 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 MQV device

  1. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K060794Progenix DBM Putty and Paste
Summary page 2
…onstrates PROGENIXTM DBM Putty to be substantially equivalent to previously cleared bone void fillers such as PROGENIX TM DBM Putty (Medtronic Sofamor Danek, K060794, SE 12/18/06), Connexus Putty (K050690, SE 07/07/05), Actifuse TM ABX E-Z-fil Putty Bone Graft Substitute (ApaTech Li…
Medtronic Sofamor Danek2006—
*K050690Connexus
Summary page 2
…bstantially equivalent to previously cleared bone void fillers such as PROGENIX TM DBM Putty (Medtronic Sofamor Danek, K060794, SE 12/18/06), Connexus Putty (K050690, SE 07/07/05), Actifuse TM ABX E-Z-fil Putty Bone Graft Substitute (ApaTech Limited, K071206, SE 5/31/07), DBX Demineralize…
Isotis Orthobiologics, Inc.2005—
*K071206Actifuse Abx E-Z-Fil Putty Bone Graft Substitute
Summary page 2
…(Medtronic Sofamor Danek, K060794, SE 12/18/06), Connexus Putty (K050690, SE 07/07/05), Actifuse TM ABX E-Z-fil Putty Bone Graft Substitute (ApaTech Limited, K071206, SE 5/31/07), DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040262, SE 03/17/05),…
Apatech, Ltd.20071
*K040262DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix
Summary page 2
…fil Putty Bone Graft Substitute (ApaTech Limited, K071206, SE 5/31/07), DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040262, SE 03/17/05), and ALLOMATRIX® Putty (Wright Medical Technology, K041168, SE 08/02/04). VI. Osteoinductivity Potential…
Musculoskeletal Transplant Foundation20052
*K041168Allomatrix Putty
Summary page 2
…BX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040262, SE 03/17/05), and ALLOMATRIX® Putty (Wright Medical Technology, K041168, SE 08/02/04). VI. Osteoinductivity Potential All DBM used in the preparation of PROGENIXTM DBM Putty must induce bone…
Wrightmedicaltechnologyinc2004—

Also cleared against K060794: 2 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080462Progenix DBM PuttyMedtronic Sofamor Danek20082
K082002Progenix PlusMedtronic Sofamor Danek20080

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 11 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 5 of the 22 ancestors have a recall of any class.
  • Of its descendants, K080462 (Medtronic Sofamor Danek, 2008) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K060794.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MQV

14in 2025

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

PROGENIXTMDBM Putty is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). 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. When used in the extremeties or pelvis, the device is used by itself. When used in the spine, the device must be mixed with autograft bone and used as a bone graft extender.

Indications for use as stated in the FDA summary.

Also cleared against K060794

2 other devices cite the same predicate.

  • K132868CarricellEtex Corporation · 2015
  • K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008

More from Medtronic Sofamor Danek

154 FDA decisions under this applicant name. See the company

  • K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek · 2021
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  • K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
  • K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek · 2017
  • K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017

Recent decisions in MQV

The MQV category page

  • K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026
  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K253524Adaptos®Fuse Bone GraftBiomendex OY · 2026

https://510kreport.com/device/K072265 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072265: Progenix DMB Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072265

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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