510(k) Report

510(k) · Cleared

Cleared

Novabone-Bioglass Bone Graft Particulate

K000149510(k) SpecialCleared Feb 7, 200019-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Usbiomaterials Corp. · LYC Bone Grafting Material, Synthetic

Cleared on Feb 7, 2000 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 188 later devices descend from it.

Decided
Feb 7, 2000
Review
19 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
0

188 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2008: 8 descendants cleared2007: 8 descendants cleared2004: 3 descendants cleared2003: 2 descendants cleared2006: 5 descendants cleared2010: 9 descendants cleared2005: 2 descendants cleared2025: 20 descendants cleared2016: 5 descendants cleared2011: 8 descendants cleared2009: 10 descendants cleared2012: 6 descendants cleared2019: 7 descendants cleared2014: 8 descendants cleared2015: 5 descendants cleared2013: 4 descendants cleared2026: 14 descendants cleared2018: 8 descendants cleared2021: 8 descendants cleared2023: 14 descendants cleared2020: 2 descendants cleared2024: 17 descendants cleared2022: 9 descendants cleared2017: 6 descendants cleared200020052010201520202025
  1. This deviceK000149 Novabone-Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 2000
  2. Descendant · cites it directly · 85 of its ownK033994 Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  3. Descendant · 2 generations on · 84 of its ownK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  4. Descendant · cites it directly · 80 of its ownK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
  5. Descendant · 3 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
  6. Descendant · 4 generations on · 47 of its ownK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010

Showing 5 of 188 descendants. See all descendants

Descendants cleared per year

2003: 22004: 32005: 22006: 52007: 82008: 82009: 102010: 92011: 82012: 62013: 42014: 82015: 52016: 52017: 62018: 82019: 72020: 22021: 82022: 92023: 142024: 172025: 202026: 14
2003high 20 (2025) · low 2 (2003)2026

Most influential descendants

Showing 5 of 188 · See all
  • K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · cites it directly85descendants
  • K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on84descendants
  • K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004 · cites it directly80descendants
  • K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 3 generations on59descendants
  • K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010 · 4 generations on47descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000149Novabone-Bioglass Bone Graft ParticulateUsbiomaterials Corp.2000—
+1K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC2004—
+2K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC2004—
+1K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC2004—
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC2008—
+4K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200430
200520
200650
200780
200880
2009100
201090
201180
201260
201340
201480
201550
201650
201760
201880
201970
202020
202180
202290
2023140
2024170
2025200
2026140
FIG. 1 — Lineage of K000149, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYC? 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 LYC device

  1. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (188)

See all 188

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

NumberDeviceApplicantDecidedDescendants
K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC200485
K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC200480
K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.200816
K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc.200315
K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613
K070998Inion BiorestoreInion OY20074
K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074
K070784Inion BiorestoreInion OY20070

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?

  • Of its descendants, K033994 (Novabone Products, LLC, 2004) has gone furthest, with 85 descendants of its own.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, 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
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

More from Usbiomaterials Corp.

5 FDA decisions under this applicant name. See the company

  • K024343Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
  • K992416Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1999
  • K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
  • K930115PerioglassUsbiomaterials Corp. · 1993

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K000149 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000149: Novabone-Bioglass Bone Graft Particulate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000149

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026