510(k) Report

510(k) · Cleared

Cleared

Novabone Porous-Bone Graft Scaffold

K060432510(k) TraditionalCleared Apr 4, 200642-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 Apr 4, 2006 as substantially equivalent to K021336 (Novabone Products, LLC, 2002) and 1 other predicate after a 42-day review. Its family tree reaches back 3 generations to 1996. 19 later devices descend from it.

Decided
Apr 4, 2006
Review
42 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K960978 (1996). 5 ancestors in all. 19 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1997: 1 other ancestor2011: 2 descendants cleared2009: 2 descendants cleared2007: 1 descendant cleared2014: 3 descendants cleared2015: 3 descendants cleared2019: 3 descendants cleared2018: 2 descendants cleared2016: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant 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. · 1998K021336 · Novabone-Resorbable Bone Graft Substitute · Novabone Products, LLC · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 6 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K021336 · Novabone-Resorbable Bone Graft Substitute · Novabone Products, LLC · 2002K980817 · 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
  1. Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 1 generation backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
  4. This deviceK060432 Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC · 2006
  5. Descendant · cites it directly · 10 of its ownK090731 Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC · 2009
  6. Descendant · cites it directly · 6 of its ownK140946 Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive…Novabone Products, LLC · 2014
  7. Descendant · cites it directly · 4 of its ownK070998 Inion BiorestoreInion OY · 2007
  8. Descendant · 2 generations on · 3 of its ownK180080 FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 2018
  9. Descendant · cites it directly · 2 of its ownK141189 Nanobone / GranulateArtoss GmbH · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2007: 12009: 22011: 22014: 32015: 32016: 12018: 22019: 32022: 12025: 1
2007high 3 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 19 · See all
  • K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC · 2009 · cites it directly10descendants
  • K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC · 2014 · cites it directly6descendants
  • K070998Inion BiorestoreInion OY · 2007 · cites it directly4descendants
  • K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 2018 · 2 generations on3descendants
  • K141189Nanobone / GranulateArtoss GmbH · 2015 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−2K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−1K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC2002—
0 (this device)K060432Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC2006—
+1K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC2009—
+1K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC2014—
+1K070998Inion BiorestoreInion OY2007—
+2K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.2018—
+1K141189Nanobone / GranulateArtoss GmbH2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200920
201120
201430
201530
201610
201820
201930
202210
202510
FIG. 1 — Lineage of K060432, 1996–2025Source: 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? (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
*K021336Novabone-Resorbable Bone Graft Substitute
Summary page 1
…: Unknown 3. Legally Marketed Predicate Device: Predicate # 1: NovaBone - Resorbable Bone Graft Substitute [K02 1336] Predicate #2: ProOsteon 50OR - Resorbable Bone Graft [K990131] 4.…
Novabone Products, LLC2002—
*K990131Pro Osteon Implant 500R Resorbable Bone Graft Substitute
Summary page 1
…ft Substitute [K02 1336] Predicate #2: ProOsteon 50OR - Resorbable Bone Graft [K990131] 4. Device Description NovaBone Porous is an osteoconductive bioactive device. It is a one-component,…
Interpore Cross Intl.1999—

Also cleared against K021336: 12 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910
K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146
K070998Inion BiorestoreInion OY20074
K141189Nanobone / GranulateArtoss GmbH20152
K141207Novabone Bioactive StripNovabone Products, LLC20140
K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110
K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110

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 10 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K090731 (Novabone Products, LLC, 2009) has gone furthest, with 10 descendants of its own.
  • 12 other devices also cite its predicate K021336.

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 Porous - Bone Graft Scaffold is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Porous is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities 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 K021336

12 other devices cite the same predicate.

  • K112857Interface Bone Void FillerBiostructures, LLC · 2011
  • K092541InterfaceBiostructures · 2010
  • K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
  • K071199Bonalive GranulesVivoxid, Ltd. · 2008
  • K070998Inion BiorestoreInion OY · 2007
  • K062459Origen DBM with Bioactive GlassNanotherapeutics · 2007

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/K060432 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060432: Novabone Porous-Bone Graft Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060432

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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