510(k) Report

510(k) · Cleared

Cleared

Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone Void Filler (1CC, 2CC, 5CC, 10CC,

K121989510(k) TraditionalCleared Nov 27, 2012144-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

Exactech, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Nov 27, 2012 as substantially equivalent to K050806 (Exactech, Inc., 2006) and 8 other predicates after a 144-day review. Its family tree reaches back 6 generations to 1999. 1 later device descends from it.

Decided
Nov 27, 2012
Review
144 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
9

Its longest line of descent runs back 6 generations to K990131 (1999). 30 ancestors in all, the oldest K963562 (1997). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 3 other ancestors2008: 1 other ancestor2007: 2 other ancestors2006: 2 other ancestors2005: 7 other ancestors2004: 4 other ancestors2001: 2 other ancestors2000: 1 other ancestor1997: 1 other ancestor2025: 1 descendant clearedK990131 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute · Interpore Cross Intl. · 1999K020986 · Mastergraft Resorbable Ceramic · Medtronic Sofamor Danek, Inc. · 2002K032268 · MBCP · Biomatlante · 2003K043005 · Modification to MBCP · Biomatlante · 2005K050806 · Optecure · Exactech, Inc. · 2006K061668 · Optecure +CCC · Exactech, Inc. · 20061995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 9 other ancestors3 generations back: 2 other ancestors4 generations back: 6 other ancestors 1 generation forward: 1 descendant K061668 · Optecure +CCC · Exactech, Inc. · 2006K050806 · Optecure · Exactech, Inc. · 2006K043005 · Modification to MBCP · Biomatlante · 2005K032268 · MBCP · Biomatlante · 2003K020986 · Mastergraft Resorbable Ceramic · Medtronic Sofamor Danek, Inc. · 2002K990131 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute · Interpore Cross Intl. · 1999−50
  1. Root · 6 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
  2. 5 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
  3. 4 generations backK032268 MBCPBiomatlante · 2003
  4. 3 generations backK043005 Modification to MBCPBiomatlante · 2005
  5. 2 generations backK050806 OptecureExactech, Inc. · 2006
  6. 1 generation backK061668 Optecure +CCCExactech, Inc. · 2006
  7. This deviceK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
  8. Descendant · cites it directly · 0 of its ownK241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K990131Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl.1999—
−5K020986Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc.2002—
−4K032268MBCPBiomatlante2003—
−3K043005Modification to MBCPBiomatlante2005—
−2K050806OptecureExactech, Inc.2006—
−1K061668Optecure +CCCExactech, Inc.2006—
0 (this device)K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +…Exactech, Inc.2012—
+1K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200120
200440
200570
200620
200720
200810
201130
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K121989, 1999–2025Source: 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? (9)

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
*K050806Optecure
Summary page 1
…bstantial Equivalence Comparison: Produc Code Manufacturer 510(k) Number Product MQV, MBP Exactech Inc. K050806 Optecure MQV, MEP Exactech, Inc. K061668 Optecure+CCC MQV, MIBP…
Exactech, Inc.2006—
*K061668Optecure +CCC
Summary page 1
…510(k) Number Product MQV, MBP Exactech Inc. K050806 Optecure MQV, MEP Exactech, Inc. K061668 Optecure+CCC MQV, MIBP Musculoskeletal K1 10003 MTF New Bone Void…
Exactech, Inc.2006—
*K110003MTF New Bone Void Filler
Summary page 1
…K050806 Optecure MQV, MEP Exactech, Inc. K061668 Optecure+CCC MQV, MIBP Musculoskeletal K1 10003 MTF New Bone Void Transplant K1 13167 Filler _____________Founa…
Musculoskeletal Transplant Foundation2011—
*K113167MTF New Bone Voild Filler
Summary page 1
…Optecure+CCC MQV, MIBP Musculoskeletal K1 10003 MTF New Bone Void Transplant K1 13167 Filler _____________Founation _________ MQV, MBP Musculoskeletal…
Musculoskeletal Transplant Foundation2012—
*K053218DBX Demineralized Bone Matrix Putty/Paste/Mix
Summary page 1
…ansplant K1 13167 Filler _____________Founation _________ MQV, MBP Musculoskeletal K053218 DBX Demineralized Transplant K063676 Bone Matrix Putty…
Musculoskeletal Transplant Foundation2006—
*K063676DBX Demineralized Bone Matrix Mix
Summary page 1
…_________ MQV, MBP Musculoskeletal K053218 DBX Demineralized Transplant K063676 Bone Matrix Putty Founation K080399…
Musculoskeletal Transplant Foundation2007—
*K080399DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix Paste
Summary page 1
…DBX Demineralized Transplant K063676 Bone Matrix Putty Founation K080399 K103784 ____________K103795…
Musculoskeletal Transplant Foundation2008—
*K103784DBX Demineralized Bone Matrix Putty
Summary page 1
…t K063676 Bone Matrix Putty Founation K080399 K103784 ____________K103795 __________…
Musculoskeletal Transplant Foundation2011—
*K103795DBX Demineralized Bone Matrix Putty
Summary page 1
…y Founation K080399 K103784 ____________K103795 __________ Pagel1 of3…
Musculoskeletal Transplant Foundation2011—

Also cleared against K050806: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250

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 13 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
  • 5 of the 30 ancestors have a recall of any class.
  • Of its descendants, K241555 (Rti Surgical, Inc., 2025) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K050806.

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. 2012, 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?

Optecure and Optecure +CCC are intended for use in combination with autogenous bone as a bone graft extender (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Optecure and Optecure + CCC can be used with autogenous bone marrow. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Optecure and Optecure ±CCC may be used with rigid fixation systems.

Indications for use as stated in the FDA summary.

Also cleared against K050806

1 other device cites the same predicate.

  • K061668Optecure +CCCExactech, Inc. · 2006

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

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/K121989 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121989: Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone Void Filler (1CC, 2CC, 5CC, 10CC,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121989

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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