510(k) Report

510(k) · Cleared

Cleared

Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-Xyz Series, GO-DZ Series

K050666510(k) TraditionalCleared Apr 11, 200528-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 Apr 11, 2005 as substantially equivalent to K023703 (Berkeley Advanced Biomaterials, Inc., 2003) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 2000.

Decided
Apr 11, 2005
Review
28 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K994337 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestorK994337 · Vitoss Scaffold Synthetic Cancellous Bone Void Filler · Orthovita Co. · 20002000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K994337 · Vitoss Scaffold Synthetic Cancellous Bone Void Filler · Orthovita Co. · 20000
  1. Root · 1 generation backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
  2. This deviceK050666 Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G…Berkeley Advanced Biomaterials, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K994337Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co.2000—
0 (this device)K050666Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G…Berkeley Advanced Biomaterials, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K050666, 2000–2005Source: 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
*K023703BI-Ostetic
Summary page 1
…ant is bioresorbable and radio-opaque. C. SUBSTANTIAL EQUIVALENCE INFORMATION GenerOSTM is substantially equivalent to legally marketed, predicate devices Bi-Ostetic (K023703) and Vitoss (K994337). The products have identical indlications-for-use, identical or very similar composition, and equivalent c…
Berkeley Advanced Biomaterials, Inc.2003—
*K994337Vitoss Scaffold Synthetic Cancellous Bone Void Filler
Summary page 1
…and radio-opaque. C. SUBSTANTIAL EQUIVALENCE INFORMATION GenerOSTM is substantially equivalent to legally marketed, predicate devices Bi-Ostetic (K023703) and Vitoss (K994337). The products have identical indlications-for-use, identical or very similar composition, and equivalent contraindications. The…
Orthovita Co.2000—

Also cleared against K023703: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.
  • 3 other devices also cite its predicate K023703.

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?

GenerOsTM 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 GenerOsTM granules or blocks provide void…

Read the full statement (115 words)

GenerOsTM 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 GenerOsTM 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. GenerOsTM is biocompatible and resorbs in the body as bone ingrowth occurs.

Indications for use as stated in the FDA summary.

Also cleared against K023703

3 other devices cite the same predicate.

  • K062691ComporusTakiron Co., Ltd. · 2008
  • K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC · 2005
  • K042636BioplusBerkeley Advanced Biomaterials, Inc. · 2004

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/K050666 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050666: Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-Xyz Series, GO-DZ Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050666

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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