510(k) · Cleared
ClearedProgenix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · NUN Bone Grafting Material, Human Source
Cleared on Nov 10, 2008 as substantially equivalent to K080462 (Medtronic Sofamor Danek, 2008) and 2 other predicates after a 75-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Nov 10, 2008
- Review
- 75 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K963562 (1997). 34 ancestors in all, the oldest K960978 (1996). No later device cites it as a predicate yet.
- Root · 8 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 7 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 6 generations backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
- 5 generations backK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
- 4 generations backK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
- 3 generations backK072265 Progenix DMB PuttyMedtronic Sofamor Danek · 2008
- 2 generations backK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- 1 generation backK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
- This deviceK082463 ProgenixMedtronic Sofamor Danek · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −7 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −6 | K040755 | Exactech Resorbable Room Temperature Bone Paste | Exactech, Inc. | 2004 | — |
| −5 | K043048 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | 15 |
| −4 | K060794 | Progenix DBM Putty and Paste | Medtronic Sofamor Danek | 2006 | — |
| −3 | K072265 | Progenix DMB Putty | Medtronic Sofamor Danek | 2008 | — |
| −2 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| −1 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| 0 (this device) | K082463 | Progenix | Medtronic Sofamor Danek | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080462 | Progenix DBM PuttySummary page 1…deled and is replaced by host bone during the healing process. The subject is identical to previously cleared predicate devices (K081950, SE 7/18/2008, K080462, SE 5/13/2008). PROGENIX Mendtrcnin Cnnfidnntinl… | 2008 |
| * | K081950 | Progenix PlusSummary page 1…r that is resorbed/remodeled and is replaced by host bone during the healing process. The subject is identical to previously cleared predicate devices (K081950, SE 7/18/2008, K080462, SE 5/13/2008). PROGENIX Mendtrcnin Cnnfidnntinl… | 2008 |
| * | K051188 | Grafton DBMSummary page 2…(Medtronic Sofamor Danek, K080462, SE 5/13/2008), PROGENIX® Plus(Medtronic Sofamor Danek, K081950, SE 7/18/2008), and GRAFTON® DBM (Osteotech, Inc., K051188, SE 01/03/2006). PROGENIX Mldtrnnin. Cnnfild1nti1 _Al… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 34 ancestors have a recall of any class.
- 1 other device also cites its predicate K080462.
How does its category compare?
All NUN devicesNUN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NUN
75in 2008
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
MAUDE reports naming product code NUN, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 75 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 25 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender, substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty…
Read the full statement (204 words)
PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender, substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.
PROGENIX® DBM Putty and PROGENIX® Plus are intended to be used alone or in combination with autogenous bone and/ or bone marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral maxillofacial 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.
https://510kreport.com/device/K082463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082463: Progenix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082463
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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