510(k) Report

510(k) · Cleared

Cleared

Ebi Osteostim Granules-Resorbable Bone Graft Substitute

K011386510(k) TraditionalCleared Aug 3, 200188-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

Ebi, L.P. · MQV Filler, Bone Void, Calcium Compound

Cleared on Aug 3, 2001 after an 88-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
Aug 3, 2001
Review
88 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

188 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2006: 4 descendants cleared2008: 12 descendants cleared2005: 3 descendants cleared2014: 12 descendants 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 cleared200020052010201520202025
  1. This deviceK011386 Ebi Osteostim Granules-Resorbable Bone Graft SubstituteEbi, L.P. · 2001
  2. Descendant · cites it directly · 186 of its ownK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
  3. Descendant · 2 generations on · 120 of its ownK060728 Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006
  4. Descendant · 3 generations on · 71 of its ownK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
  5. Descendant · 3 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
  6. Descendant · 3 generations on · 51 of its ownK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007

Showing 5 of 188 descendants. See all descendants

Descendants cleared per year

2004: 32005: 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 2 (2012)2026

Most influential descendants

Showing 5 of 188 · See all
  • K020078Exactech Resorbable Bone PasteExactech, Inc. · 2004 · cites it directly186descendants
  • K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC · 2006 · 2 generations on120descendants
  • K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008 · 3 generations on71descendants
  • K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 3 generations on59descendants
  • K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007 · 3 generations on51descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011386Ebi Osteostim Granules-Resorbable Bone Graft SubstituteEbi, L.P.2001—
+1K020078Exactech Resorbable Bone PasteExactech, Inc.2004—
+2K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006—
+3K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC2008—
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC2008—
+3K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200430
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 K011386, 2001–2026Source: 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 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?

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

What descends from it? (188)

See all 188

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

NumberDeviceApplicantDecidedDescendants
K020078Exactech Resorbable Bone PasteExactech, Inc.2004186
K033611Calcigen -Nap Bone Void FillerBiomet, Inc.20040

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, K020078 (Exactech, Inc., 2004) has gone furthest, with 186 descendants of its own.

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—

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

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  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

Recent decisions in MQV

The MQV category page

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  • 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/K011386 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011386: Ebi Osteostim Granules-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/K011386

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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