510(k) Report

510(k) · Cleared

Cleared

DBX Demineralized Bone Matrix Putty

K091217510(k) TraditionalCleared Oct 2, 2009158-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

Musculoskeletal Transplant Foundation · NUN Bone Grafting Material, Human Source

Cleared on Oct 2, 2009 as substantially equivalent to K040262 (Musculoskeletal Transplant Foundation, 2005) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided
Oct 2, 2009
Review
158 days
Class
Class II
Product code
NUN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K040262 (2005). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2014: 1 descendant clearedK040262 · DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix · Musculoskeletal Transplant Foundation · 2005 · recalled20052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant K040262 · DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix · Musculoskeletal Transplant Foundation · 2005 · recalled0
  1. Root · 1 generation backK040262 DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone…Musculoskeletal Transplant Foundation · 2005 · Recalled
  2. This deviceK091217 DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009
  3. Descendant · cites it directly · 0 of its ownK130235 Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040262DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixMusculoskeletal Transplant Foundation20052
0 (this device)K091217DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation2009—
+1K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K091217, 2005–2014Source: 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? (2)

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
*K040262DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix
Summary page 1
…vices DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 5 10(k) K040262 Sygnal TM DBM Musculoskeletal Transplant Foundation…
Musculoskeletal Transplant Foundation20052
*K080405Sygnal DBM
Summary page 1
…5 10(k) K040262 Sygnal TM DBM Musculoskeletal Transplant Foundation 5 10(k) K080405 Osteoinductive Potential: DBX®Inject is osteoconductive, and has been shown to have osteoinductive potential in a…
Musculoskeletal Transplant Foundation2008—

Also cleared against K040262: 12 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp.20140

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K130235 (Hans Biomed Corp., 2014) has gone furthest, with 0 descendants of its own.
  • 12 other devices also cite its predicate K040262.

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. 2009, 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?

DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows: Indications for Use Putty Paste Ridge augmentation Filling of extraction sites Craniofacial augmentation Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling resection defects in benign tumors, benign cysts, or…

Read the full statement (129 words)

DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows:

Indications for Use Putty Paste

Ridge augmentation

Filling of extraction sites

Craniofacial augmentation

Mandibular reconstruction

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

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

Filling of cystic defect

Filling of lesions of periodontal origin

Filling of defects of endodontic origin _/ _/

DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

Indications for use as stated in the FDA summary.

Also cleared against K040262

12 other devices cite the same predicate.

  • K121313MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013
  • K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
  • K103784DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011
  • K103795DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011
  • K091218DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2009
  • K091321Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. · 20092 recalls

More from Musculoskeletal Transplant Foundation

24 FDA decisions under this applicant name. See the company

  • K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation · 20191 recall
  • K121313MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013
  • K120479MTF FasciaMusculoskeletal Transplant Foundation · 2012
  • K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
  • K110003MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011

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
  • K082463ProgenixMedtronic Sofamor Danek · 2008
  • K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008

https://510kreport.com/device/K091217 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091217: DBX Demineralized Bone Matrix Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091217

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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