510(k) Report

510(k) · Cleared

Cleared

Progenix DBM Putty

K080462510(k) TraditionalCleared May 13, 200883-day reviewClass II21 CFR 872.3930

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

Medtronic Sofamor Danek · NUN Bone Grafting Material, Human Source

Cleared on May 13, 2008 as substantially equivalent to K072265 (Medtronic Sofamor Danek, 2008) and 5 other predicates after an 83-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.

Decided
May 13, 2008
Review
83 days
Class
Class II
Product code
NUN
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K963562 (1997). 32 ancestors in all, the oldest K960978 (1996). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 2 other ancestors2006: 2 other ancestors2005: 7 other ancestors2004: 4 other ancestors2001: 3 other ancestors2000: 2 other ancestors1998: 2 other ancestors1996: 2 other ancestors2003: 1 other ancestor2002: 1 other ancestor2008: 2 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 · 2006K072265 · Progenix DMB Putty · Medtronic Sofamor Danek · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 9 other ancestors3 generations back: 6 other ancestors4 generations back: 4 other ancestors5 generations back: 2 other ancestors6 generations back: 1 other ancestor 1 generation forward: 2 descendants K072265 · Progenix DMB Putty · Medtronic Sofamor Danek · 2008K060794 · 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 · 6 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
  2. 5 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
  3. 4 generations backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
  4. 3 generations backK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
  5. 2 generations backK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
  6. 1 generation backK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
  7. This deviceK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
  8. Descendant · cites it directly · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
  9. Descendant · cites it directly · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · cites it directly1descendant
  • K082463ProgenixMedtronic Sofamor Danek · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K963562Wright Plaster of Paris PelletsWrightmedicaltechnologyinc1997—
−5K020078Exactech Resorbable Bone PasteExactech, Inc.2004—
−4K040755Exactech Resorbable Room Temperature Bone PasteExactech, Inc.2004—
−3K043048Grafton Plus DBM PasteOsteotech, Inc.200515
−2K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek2006—
−1K072265Progenix DMB PuttyMedtronic Sofamor Danek2008—
0 (this device)K080462Progenix DBM PuttyMedtronic Sofamor Danek2008—
+1K081950Progenix PlusMedtronic Sofamor Danek, Inc.2008—
+1K082463ProgenixMedtronic Sofamor Danek2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199820
200020
200130
200210
200310
200440
200570
200620
200720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
FIG. 1 — Lineage of K080462, 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 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
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What was it cleared against? (6)

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
*K072265Progenix DMB Putty
Summary page 2
…monstrates PROGENIXTM DBM Putty to be substantially equivalent to previously cleared bone void fillers such as PROGENIXTM DBM Putty (Medtronic Sofamor Danek, K072265, SE 1/9/2008), PROGENIX TM DBM Putty (Medtronic Sofamor Danek, K060794, SE 12/18/06), DBX Demineralized Bone Matrix P…
Medtronic Sofamor Danek2008—
*K060794Progenix DBM Putty and Paste
Summary page 2
…ously cleared bone void fillers such as PROGENIXTM DBM Putty (Medtronic Sofamor Danek, K072265, SE 1/9/2008), PROGENIX TM DBM Putty (Medtronic Sofamor Danek, K060794, SE 12/18/06), DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040501, SE 04/2…
Medtronic Sofamor Danek2006—
*K040501DBX Demineralized Bone Matrix Putty, Paste and Mix
Summary page 2
…PROGENIX TM DBM Putty (Medtronic Sofamor Danek, K060794, SE 12/18/06), DBX Demineralized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040501, SE 04/29/05), Accell Connexus TM DBM Putty (IsoTis, OrthoBiologics, Inc., K060306, SE 03/27/2006), Intergo® Oral (Bi…
Musculoskeletal Transplant Foundation2005—
*K060306Accell Connexus Demineralized Bone Matrix Putty
Summary page 2
…alized Bone Matrix Putty and Paste (Musculoskeletal Transplant Foundation, K040501, SE 04/29/05), Accell Connexus TM DBM Putty (IsoTis, OrthoBiologics, Inc., K060306, SE 03/27/2006), Intergo® Oral (Biomet 3i, K070147, SE 05/14/2007), and GRAFTON® DBM (Osteotech, Inc., K051188, SE 01…
Isotis NV2006—
*K070147Intergro Oral
Summary page 2
…Transplant Foundation, K040501, SE 04/29/05), Accell Connexus TM DBM Putty (IsoTis, OrthoBiologics, Inc., K060306, SE 03/27/2006), Intergo® Oral (Biomet 3i, K070147, SE 05/14/2007), and GRAFTON® DBM (Osteotech, Inc., K051188, SE 01/03/2006). $S~¥1VCEs' DEPAR…
Biomet 3i2007—
*K051188Grafton DBM
Summary page 2
…us TM DBM Putty (IsoTis, OrthoBiologics, Inc., K060306, SE 03/27/2006), Intergo® Oral (Biomet 3i, K070147, SE 05/14/2007), and GRAFTON® DBM (Osteotech, Inc., K051188, SE 01/03/2006). $S~¥1VCEs' DEPARTMENT OF HEALTH & HUMAN SERVICES…
Osteotech, Inc.200614

Also cleared against K072265: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081
K082463ProgenixMedtronic 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.
  • 6 of the 32 ancestors have a recall of any class.
  • Of its descendants, K081950 (Medtronic Sofamor Danek, Inc., 2008) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K072265.

How does its category compare?

All NUN devices

NUN Bone Grafting Material, Human Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NUN

1in 2014

2007: 12008: 42009: 12011: 12012: 12014: 1
2007high 4 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUN

75in 2008

2008: 75 days median
2007high 75 (2008)2026

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

2009: 12010: 62011: 132012: 152013: 252014: 22015: 62016: 12017: 102018: 42019: 102020: 62021: 62022: 32024: 22025: 6
2007high 25 (2013) · low 0 (2007)2025

MAUDE reports naming product code NUN, 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
20071—00
200847500
20091—01
20100—06
20111—013
20121—015
20130—025
20141—02
20150—06
20160—01
20170—010
20180—04
20190—010
20200—06
20210—06
20220—03
20230—00
20240—02
20250—06
20260—0—

What is it indicated for?

PROGENIX TM DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation

Filling of cystic defect

Filling of extraction sites

Filling of lesions of periodontal origin

Craniofacial augmentation

Filling of defects of endodontic origin

Mandibular reconstruction

Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

Indications for use as stated in the FDA summary.

Also cleared against K072265

1 other device cites the same predicate.

  • K082002Progenix PlusMedtronic 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 NUN

The NUN category page

  • K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014
  • K113645Regeneross Allograft Plus MinerlizedBiomet Interpore Cross · 2012
  • K103699Eactech Optecure Dental and Optecure Dental + CCCExactech, Inc. · 2011
  • K091217DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009
  • K082463ProgenixMedtronic Sofamor Danek · 2008

https://510kreport.com/device/K080462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080462: Progenix DBM Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080462

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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