510(k) Report

510(k) · Cleared

Cleared

Exactech Resorbable Bone Paste

K020078510(k) TraditionalCleared Feb 27, 2004779-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 Feb 27, 2004 as substantially equivalent to K963562 (Wrightmedicaltechnologyinc, 1997) and 2 other predicates after a 779-day review. Its family tree reaches back 1 generation to 1997. 186 later devices descend from it.

Decided
Feb 27, 2004
Review
779 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K963562 (1997). 3 ancestors in all. 186 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2006: 4 descendants cleared2008: 12 descendants cleared2005: 3 descendants cleared2014: 12 descendants cleared2004: 1 descendant cleared2007: 3 descendants cleared2009: 12 descendants cleared2024: 17 descendants cleared2011: 10 descendants cleared2017: 6 descendants cleared2010: 8 descendants cleared2015: 8 descendants cleared2013: 4 descendants cleared2018: 10 descendants cleared2019: 5 descendants cleared2021: 10 descendants cleared2026: 11 descendants cleared2023: 15 descendants cleared2022: 10 descendants cleared2012: 2 descendants cleared2016: 3 descendants cleared2020: 2 descendants cleared2025: 18 descendants clearedK963562 · Wright Plaster of Paris Pellets · Wrightmedicaltechnologyinc · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 8 descendants2 generations forward: 35 descendants3 generations forward: 49 descendants4 generations forward: 53 descendants5 generations forward: 30 descendants6 generations forward: 9 descendants7 generations forward: 2 descendants K963562 · Wright Plaster of Paris Pellets · Wrightmedicaltechnologyinc · 19970+5
  1. Root · 1 generation backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
  2. This deviceK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
  3. Descendant · cites it directly · 120 of its ownK060728 Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006
  4. Descendant · 2 generations on · 71 of its ownK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
  5. Descendant · 2 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
  6. Descendant · 2 generations on · 51 of its ownK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
  7. Descendant · 3 generations on · 50 of its ownK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008

Showing 5 of 186 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 42007: 32008: 122009: 122010: 82011: 102012: 22013: 42014: 122015: 82016: 32017: 62018: 102019: 52020: 22021: 102022: 102023: 152024: 172025: 182026: 11
2004high 18 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 186 · See all
  • K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006 · cites it directly120descendants
  • K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008 · 2 generations on71descendants
  • K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 2 generations on59descendants
  • K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007 · 2 generations on51descendants
  • K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008 · 3 generations on50descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963562Wright Plaster of Paris PelletsWrightmedicaltechnologyinc1997—
0 (this device)K020078Exactech Resorbable Bone PasteExactech, Inc.2004—
+1K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006—
+2K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC2008—
+2K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC2008—
+2K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.2007—
+3K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200640
200730
2008120
2009120
201080
2011100
201220
201340
2014120
201580
201630
201760
2018100
201950
202020
2021100
2022100
2023150
2024170
2025180
2026110
FIG. 1 — Lineage of K020078, 1997–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K963562Wright Plaster of Paris Pellets
Summary page 1
…for Substantial Equivalence Comparison: Product Code Manufacturer 51()Number Product MQV Wright K963562 Wright Plaster of Paris Pellets MQV EBI K01 1386 EBI Osteost…
Wrightmedicaltechnologyinc1997—
*K011386Ebi Osteostim Granules-Resorbable Bone Graft Substitute
Summary page 1
…Product MQV Wright K963562 Wright Plaster of Paris Pellets MQV EBI K01 1386 EBI Osteostim Granules - Resorbable Bone Graf…
Ebi, L.P.2001—
*K000122Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6…
Summary page 1
…ostim Granules - Resorbable Bone Graft Substitute MQV Neu Coil Laboratories K000122 Collagraft Strip Bone Graft Matrix 4. Comparison to the Predicate Device(s): Exactech Resorbable Bone Paste…
Neucoll, Inc.2001—

Also cleared against K963562: 8 other devices →

What descends from it? (186)

See all 186

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

NumberDeviceApplicantDecidedDescendants
K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120
K053098Optium DBM Gel and PuttyLifenet200539
K080917Iroot SPInnovative Bioceramix, Inc.200837
K040755Exactech Resorbable Room Temperature Bone PasteExactech, Inc.200416
K043048Grafton Plus DBM PasteOsteotech, Inc.200510
K132071Bioactive Bone Graft PuttyBiostructures, LLC20146
K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072
K043209Viagraf DBM PasteOsteotech, Inc.20050

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K060728 (Novabone Products, LLC, 2006) has gone furthest, with 120 descendants of its own.
  • 8 other devices also cite its predicate K963562.

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.

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?

Exactech Resorbable Bone Paste is intended for use as a bone graft extender (extremities, spine, pelvis) and as a bone void filler for bony voids or gaps of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Exactech Resorbable Bone Paste may be used with rigid fixation systems.

Indications for use as stated in the FDA summary.

Also cleared against K963562

8 other devices cite the same predicate.

  • K060809Osteo-Link Bone Void Filler PelletsPromed Advance Technology Co., Ltd. · 2006
  • K051698Merries Uni-Osteo, Model CS30250-CS10102Merries International, Inc. · 2005
  • K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
  • K031319Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003
  • K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
  • K013790Calcigen-S Bone Void FilerBiomet Orthopedics, Inc. · 2002

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/K020078 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020078: Exactech Resorbable Bone Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020078

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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