510(k) Report

510(k) · Cleared

Cleared

Novabone-Resorbable Bone Graft Substitute

K021336510(k) TraditionalCleared Jul 25, 200290-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

Novabone Products, LLC · MQV Filler, Bone Void, Calcium Compound

Cleared on Jul 25, 2002 as substantially equivalent to K980817 (Interpore Intl., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1996. 162 later devices descend from it.

Decided
Jul 25, 2002
Review
90 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K960978 (1996). 3 ancestors in all. 162 later devices descend from it, 13 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2006: 4 descendants cleared2007: 7 descendants cleared2010: 8 descendants cleared2008: 7 descendants cleared2005: 2 descendants cleared2011: 12 descendants cleared2004: 1 descendant cleared2009: 8 descendants cleared2015: 9 descendants cleared2014: 11 descendants cleared2012: 3 descendants cleared2017: 7 descendants cleared2024: 16 descendants cleared2013: 4 descendants cleared2019: 6 descendants cleared2020: 3 descendants cleared2026: 9 descendants cleared2016: 4 descendants cleared2023: 12 descendants cleared2018: 6 descendants cleared2022: 6 descendants cleared2021: 3 descendants cleared2025: 14 descendants clearedK960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 1996K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 13 descendants2 generations forward: 35 descendants3 generations forward: 36 descendants4 generations forward: 41 descendants5 generations forward: 20 descendants6 generations forward: 11 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 1998K960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 19960+5
  1. Root · 2 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 1 generation backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. This deviceK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
  4. Descendant · cites it directly · 123 of its ownK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
  5. Descendant · cites it directly · 120 of its ownK060728 Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006
  6. Descendant · cites it directly · 84 of its ownK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  7. Descendant · cites it directly · 71 of its ownK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
  8. Descendant · 2 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008

Showing 5 of 162 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 42007: 72008: 72009: 82010: 82011: 122012: 32013: 42014: 112015: 92016: 42017: 72018: 62019: 62020: 32021: 32022: 62023: 122024: 162025: 142026: 9
2004high 16 (2024) · low 1 (2004)2026

Most influential descendants

Showing 5 of 162 · See all
  • K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005 · cites it directly123descendants
  • K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006 · cites it directly120descendants
  • K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · cites it directly84descendants
  • K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008 · cites it directly71descendants
  • K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 2 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−1K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
0 (this device)K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC2002—
+1K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC2005—
+1K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006—
+1K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC2004—
+1K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC2008—
+2K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200640
200770
200870
200980
201080
2011120
201230
201340
2014110
201590
201640
201770
201860
201960
202030
202130
202260
2023120
2024160
2025140
202690
FIG. 1 — Lineage of K021336, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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
*K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…
Summary page 4
…alence NovaBone Pro Osteon 500R Wright Plaster of Paris Comparison K980817 Pellets K963562…
Interpore Intl.1998—
*K963562Wright Plaster of Paris Pellets
Summary page 4
…K980817 Pellets K963562 Intended Use A non-structural Same as new device Same as new device ost…
Wrightmedicaltechnologyinc1997—

Also cleared against K980817: 10 other devices →

What descends from it? (162)

See all 162

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

NumberDeviceApplicantDecidedDescendants
K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC2005123
K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120
K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC200484
K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871
K062459Origen DBM with Bioactive GlassNanotherapeutics200756
K060432Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC200619
K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613
K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511
K092541InterfaceBiostructures20109
K112857Interface Bone Void FillerBiostructures, LLC20118

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 6 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K052494 (Novabone Products, LLC, 2005) has gone furthest, with 123 descendants of its own.
  • 10 other devices also cite its predicate K980817.

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?

NovaBone Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

Also cleared against K980817

10 other devices cite the same predicate.

  • K062691ComporusTakiron Co., Ltd. · 2008
  • K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd. · 2007
  • K063346Pro Osteon 500REbi, L.P. · 2007
  • K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc. · 2004
  • K033611Calcigen -Nap Bone Void FillerBiomet, Inc. · 2004
  • K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003

More from Novabone Products, LLC

30 FDA decisions under this applicant name. See the company

  • K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC · 2024
  • K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC · 2024
  • K220498NovoGen Wound MatrixNovabone Products, LLC · 2023
  • K163310NovaBone IRMNovabone Products, LLC · 2017
  • K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)Novabone Products, LLC · 2015

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/K021336 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021336: Novabone-Resorbable Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021336

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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