510(k) Report

510(k) · Cleared

Cleared

MTF New Bone Void Filler

K121313510(k) TraditionalCleared Jan 11, 2013254-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

Musculoskeletal Transplant Foundation · MQV Filler, Bone Void, Calcium Compound

Cleared on Jan 11, 2013 as substantially equivalent to K110003 (Musculoskeletal Transplant Foundation, 2011) and 6 other predicates after a 254-day review. Its family tree reaches back 3 generations to 2006.

Decided
Jan 11, 2013
Review
254 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K042829 (2006). 8 ancestors in all, the oldest K040262 (2005). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2011: 2 other ancestors2005: 1 other ancestor2008: 1 other ancestorK042829 · DBX Strip · Musculoskeletal Transplant Foundation · 2006K062205 · DBX Strip · Musculoskeletal Transplant Foundation · 2007K110003 · MTF New Bone Void Filler · Musculoskeletal Transplant Foundation · 201120062008201020122014
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K110003 · MTF New Bone Void Filler · Musculoskeletal Transplant Foundation · 2011K062205 · DBX Strip · Musculoskeletal Transplant Foundation · 2007K042829 · DBX Strip · Musculoskeletal Transplant Foundation · 20060
  1. Root · 3 generations backK042829 DBX StripMusculoskeletal Transplant Foundation · 2006
  2. 2 generations backK062205 DBX StripMusculoskeletal Transplant Foundation · 2007
  3. 1 generation backK110003 MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011
  4. This deviceK121313 MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K042829DBX StripMusculoskeletal Transplant Foundation2006—
−2K062205DBX StripMusculoskeletal Transplant Foundation2007—
−1K110003MTF New Bone Void FillerMusculoskeletal Transplant Foundation2011—
0 (this device)K121313MTF New Bone Void FillerMusculoskeletal Transplant Foundation2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201120
201210
FIG. 1 — Lineage of K121313, 2006–2013Source: 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
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What was it cleared against? (7)

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
*K110003MTF New Bone Void Filler
Summary page 1
…Devices The MTF New Bone Void Filler Musculoskeletal Transplant Foundation 510(k) K1 10003, K1 13167 DBX® Deminralized Bone Matrix Musculoskeletal Transplant Fou…
Musculoskeletal Transplant Foundation2011—
*K113167MTF New Bone Voild Filler
Summary page 1
…The MTF New Bone Void Filler Musculoskeletal Transplant Foundation 510(k) K1 10003, K1 13167 DBX® Deminralized Bone Matrix Musculoskeletal Transplant Foundation…
Musculoskeletal Transplant Foundation2012—
*K040262DBX Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix Mix
Summary page 1
…13167 DBX® Deminralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262, K103784, K103795 DBX Strip® Musculoskeletal Transplant Foundation…
Musculoskeletal Transplant Foundation20052
*K103784DBX Demineralized Bone Matrix Putty
Summary page 1
…DBX® Deminralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262, K103784, K103795 DBX Strip® Musculoskeletal Transplant Foundation…
Musculoskeletal Transplant Foundation2011—
*K103795DBX Demineralized Bone Matrix Putty
Summary page 1
…DBX® Deminralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262, K103784, K103795 DBX Strip® Musculoskeletal Transplant Foundation…
Musculoskeletal Transplant Foundation2011—
*K042829DBX Strip
Summary page 1
…40262, K103784, K103795 DBX Strip® Musculoskeletal Transplant Foundation 5 10O(k) K042829, K062205 MIF® Page 1…
Musculoskeletal Transplant Foundation2006—
*K062205DBX Strip
Summary page 1
…03784, K103795 DBX Strip® Musculoskeletal Transplant Foundation 5 10O(k) K042829, K062205 MIF® Page 1…
Musculoskeletal Transplant Foundation2007—

Also cleared against K110003: 1 other device →

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 7 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 1 other device also cites its predicate K110003.

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. 2013, 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?

The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. The MTF New Bone Void Filler must be used in the posterolateral spine with bone marrow aspirate or autograft.

The MTF New Bone Void Filler is for single patient use only.

Indications for use as stated in the FDA summary.

Also cleared against K110003

1 other device cites the same predicate.

  • K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone Void Filler (1CC…Exactech, Inc. · 2012

More from Musculoskeletal Transplant Foundation

24 FDA decisions under this applicant name. See the company

  • K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation · 20191 recall
  • K120479MTF FasciaMusculoskeletal Transplant Foundation · 2012
  • K113167MTF New Bone Voild FillerMusculoskeletal Transplant Foundation · 2012
  • K110003MTF New Bone Void FillerMusculoskeletal Transplant Foundation · 2011
  • K103795DBX Demineralized Bone Matrix PuttyMusculoskeletal Transplant Foundation · 2011

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/K121313 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121313: MTF New Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121313

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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