510(k) Report

510(k) · Cleared

Cleared

Calcigen-S Bone Void Filer

K013790510(k) TraditionalCleared Jun 11, 2002209-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

Biomet Orthopedics, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Jun 11, 2002 as substantially equivalent to K960978 (Wrightmedicaltechnologyinc, 1996) and 2 other predicates after a 209-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.

Decided
Jun 11, 2002
Review
209 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K960978 (1996). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors2007: 1 descendant cleared2003: 1 descendant cleared2010: 1 descendant cleared2008: 2 descendants cleared2013: 1 descendant clearedK960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 19960
  1. Root · 1 generation backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. This deviceK013790 Calcigen-S Bone Void FilerBiomet Orthopedics, Inc. · 2002
  3. Descendant · cites it directly · 4 of its ownK031319 Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003
  4. Descendant · 2 generations on · 1 of its ownK091688 A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010
  5. Descendant · 3 generations on · 0 of its ownK121453 A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013
  6. Descendant · 2 generations on · 0 of its ownK072444 Wellgraft PE IGwowei Technology Co., Ltd. · 2008
  7. Descendant · 2 generations on · 0 of its ownK072170 Wellgraft PE IIGwowei Technology Co., Ltd. · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12008: 22010: 12013: 1
2003high 2 (2008) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K031319Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003 · cites it directly4descendants
  • K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010 · 2 generations on1descendant
  • K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013 · 3 generations on0descendants
  • K072444Wellgraft PE IGwowei Technology Co., Ltd. · 2008 · 2 generations on0descendants
  • K072170Wellgraft PE IIGwowei Technology Co., Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
0 (this device)K013790Calcigen-S Bone Void FilerBiomet Orthopedics, Inc.2002—
+1K031319Osteo-G Bone Void Filler SystemAspine USA, Inc.2003—
+2K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp.2010—
+3K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp.2013—
+2K072444Wellgraft PE IGwowei Technology Co., Ltd.2008—
+2K072170Wellgraft PE IIGwowei Technology Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
200820
201010
201310
FIG. 1 — Lineage of K013790, 1996–2013Source: 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? (3)

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
*K960978Wright Plaster of Paris Pellets (Subject to Revision)
Summary page 1
…ted Devices To Which Substantial Equivalence Is Claimed: CalcigenTM-SBone Void Filler is substantially equivalent to Wright Plaster of Paris Pellets (OsteoSetB Pellets) (K960978, K963562, K963587) and Wright Plaster of Paris Bone Void Filler Kit (CaSo, powder)(K963587) manufactured by Wright Medical Techno…
Wrightmedicaltechnologyinc1996—
*K963562Wright Plaster of Paris Pellets
Summary page 1
…es To Which Substantial Equivalence Is Claimed: CalcigenTM-SBone Void Filler is substantially equivalent to Wright Plaster of Paris Pellets (OsteoSetB Pellets) (K960978, K963562, K963587) and Wright Plaster of Paris Bone Void Filler Kit (CaSo, powder)(K963587) manufactured by Wright Medical Technology, Inc…
Wrightmedicaltechnologyinc1997—
*K963587Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)
Summary page 1
…ch Substantial Equivalence Is Claimed: CalcigenTM-SBone Void Filler is substantially equivalent to Wright Plaster of Paris Pellets (OsteoSetB Pellets) (K960978, K963562, K963587) and Wright Plaster of Paris Bone Void Filler Kit (CaSo, powder)(K963587) manufactured by Wright Medical Technology, Inc., Arling…
Wrightmedicaltechnologyinc1997—

Also cleared against K960978: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K031319Osteo-G Bone Void Filler SystemAspine USA, Inc.20034
K070864Boneplast QS Calcium Sulfate Bone Void FillerBiomet Osteobiologics20070

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 3 ancestors has a recall.
  • Of its descendants, K031319 (Aspine USA, Inc., 2003) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K960978.

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?

CalcigenTM-SBone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from a traumatic injury to the bone. CalcigenTM-S Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Indications for use as stated in the FDA summary.

Also cleared against K960978

1 other device cites the same predicate.

  • K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20…Interpore Intl. · 1998

More from Biomet Orthopedics, Inc.

35 FDA decisions under this applicant name. See the company

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 20082 recalls
  • K070955Acid Etched Lag ScrewsBiomet Orthopedics, Inc. · 2007
  • K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004

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/K013790 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013790: Calcigen-S Bone Void Filer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013790

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026