510(k) Report

510(k) · Cleared

Cleared

BI-Ostetic

K023703510(k) TraditionalCleared Jan 30, 200387-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

Berkeley Advanced Biomaterials, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Jan 30, 2003 after an 87-day review. The FDA summary names no predicate by number. 15 later devices descend from it.

Decided
Jan 30, 2003
Review
87 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

15 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 2 descendants cleared2008: 1 descendant cleared2017: 3 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared2024: 2 descendants cleared2014: 2 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK023703 BI-OsteticBerkeley Advanced Biomaterials, Inc. · 2003
  2. Descendant · cites it directly · 11 of its ownK050789 Formagraft Collagen Bone Graft MatrixR and D Medical, LLC · 2005
  3. Descendant · 2 generations on · 7 of its ownK091031 Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009
  4. Descendant · 3 generations on · 4 of its ownK110561 Fortross Bone Void FillerPioneer Surgical Technology · 2011
  5. Descendant · 4 generations on · 3 of its ownK141600 Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive…Pioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
  6. Descendant · 5 generations on · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22008: 12009: 12011: 22014: 22017: 32024: 22025: 1
2004high 3 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 15 · See all
  • K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC · 2005 · cites it directly11descendants
  • K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009 · 2 generations on7descendants
  • K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011 · 3 generations on4descendants
  • K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · 4 generations on3descendants
  • K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023703BI-OsteticBerkeley Advanced Biomaterials, Inc.2003—
+1K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC2005—
+2K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology2009—
+3K110561Fortross Bone Void FillerPioneer Surgical Technology2011—
+4K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I2014—
+5K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200810
200910
201120
201420
201730
202420
202510
FIG. 1 — Lineage of K023703, 2003–2025Source: 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?

The FDA summary names no predicate by number.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511
K062691ComporusTakiron Co., Ltd.20080
K050666Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-Xyz…Berkeley Advanced Biomaterials, Inc.20050
K042636BioplusBerkeley Advanced Biomaterials, 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, K050789 (R and D Medical, LLC, 2005) has gone furthest, with 11 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—

What is it indicated for?

Bi-OsteticTM is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The Bi-OsteticTM granules or blocks provide void…

Read the full statement (115 words)

Bi-OsteticTM is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The granules or blocks may be pressed into the void or into the surgical site by hand. The Bi-OsteticTM granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-OsteticTM is biocompatible and resorbs in the body as bone ingrowth occurs.

Indications for use as stated in the FDA summary.

More from Berkeley Advanced Biomaterials, Inc.

13 FDA decisions under this applicant name. See the company

  • K113791B-Genin, R-GeninBerkeley Advanced Biomaterials, Inc. · 2012
  • K091912B-Genin and R-GeninBerkeley Advanced Biomaterials, Inc. · 2010
  • K092046BI-Ostetic Foam and Putty, Generos Foam and PuttyBerkeley Advanced Biomaterials, Inc. · 2010
  • K053213BI-Ostetic Foam, Cem-Ostetic Foam, Tri-Ostetic Foam, Generos FoamBerkeley Advanced Biomaterials, Inc. · 2006
  • K051914Generos 80, Generos 60Berkeley Advanced Biomaterials, Inc. · 2005

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/K023703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023703: BI-Ostetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023703

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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