510(k) Report

510(k) · Cleared

Cleared

Calcigen -Nap Bone Void Filler

K033611510(k) TraditionalCleared Apr 27, 2004162-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, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Apr 27, 2004 as substantially equivalent to K011386 (Ebi, L.P., 2001) and 5 other predicates after a 162-day review. Its family tree reaches back 2 generations to 1996.

Decided
Apr 27, 2004
Review
162 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K960978 (1996). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 4 other ancestors1999: 1 other ancestor1997: 1 other ancestorK960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 1996K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 1998199619982000200220042006
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor K980817 · Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L · Interpore Intl. · 1998K960978 · Wright Plaster of Paris Pellets (Subject to Revision) · Wrightmedicaltechnologyinc · 19960
  1. Root · 2 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 1 generation backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. This deviceK033611 Calcigen -Nap Bone Void FillerBiomet, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−1K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
0 (this device)K033611Calcigen -Nap Bone Void FillerBiomet, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200140
FIG. 1 — Lineage of K033611, 1996–2004Source: 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
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What was it cleared against? (6)

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
*K011386Ebi Osteostim Granules-Resorbable Bone Graft Substitute
Summary page 1
…(21 CFR 888.3045) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * EBI OsteoStim TM Granules - Resorbable Bone Graft Substitute (EBI L.P.; K01 1386) * a-BSM® Bone Substitute Material (DePuy Orthopaedics, Inc; K01 1048) * Pro Osteon® 50OR Resorbable Bone Graft Substitute (Inter…
Ebi, L.P.2001—
*K011048BSM Bone Substitute Material
Summary page 1
…Equivalence Is Claimed: * EBI OsteoStim TM Granules - Resorbable Bone Graft Substitute (EBI L.P.; K01 1386) * a-BSM® Bone Substitute Material (DePuy Orthopaedics, Inc; K01 1048) * Pro Osteon® 50OR Resorbable Bone Graft Substitute (Interpore Cross; K990131, K980817) * Norian® SRS® Bone Void Filler (Synth…
DePuy Orthopaedics, Inc.2001—
*K990131Pro Osteon Implant 500R Resorbable Bone Graft Substitute
Summary page 1
…tute (EBI L.P.; K01 1386) * a-BSM® Bone Substitute Material (DePuy Orthopaedics, Inc; K01 1048) * Pro Osteon® 50OR Resorbable Bone Graft Substitute (Interpore Cross; K990131, K980817) * Norian® SRS® Bone Void Filler (Synthes USA; K01 1897) • 3i® Calcium Sodium Phosphate Bone Cement (Biomet, Inc; K00349…
Interpore Cross Intl.1999—
*K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…
Summary page 1
…L.P.; K01 1386) * a-BSM® Bone Substitute Material (DePuy Orthopaedics, Inc; K01 1048) * Pro Osteon® 50OR Resorbable Bone Graft Substitute (Interpore Cross; K990131, K980817) * Norian® SRS® Bone Void Filler (Synthes USA; K01 1897) • 3i® Calcium Sodium Phosphate Bone Cement (Biomet, Inc; K003493) Devic…
Interpore Intl.1998—
*K011897Norian SRS Bone Void Filler
Summary page 1
…ePuy Orthopaedics, Inc; K01 1048) * Pro Osteon® 50OR Resorbable Bone Graft Substitute (Interpore Cross; K990131, K980817) * Norian® SRS® Bone Void Filler (Synthes USA; K01 1897) • 3i® Calcium Sodium Phosphate Bone Cement (Biomet, Inc; K003493) Device Description: CalcigenT M-NaP Bone Void Filler is a syn…
Synthes (Usa)2001—
*K0034933I Calcium Sodium Phosphate Bone Cement
Summary page 1
…e Graft Substitute (Interpore Cross; K990131, K980817) * Norian® SRS® Bone Void Filler (Synthes USA; K01 1897) • 3i® Calcium Sodium Phosphate Bone Cement (Biomet, Inc; K003493) Device Description: CalcigenT M-NaP Bone Void Filler is a synthetic, self-setting paste for use as a bone graft substitute. The…
Biomet, Inc.2001—

Also cleared against K011386: 1 other device →

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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • None of the 8 ancestors has a recall.
  • 1 other device also cites its predicate K011386.

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?

Calcigen T '-NaP Bone Void Filler is intended for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

Indications for use as stated in the FDA summary.

Also cleared against K011386

1 other device cites the same predicate.

  • K020078Exactech Resorbable Bone PasteExactech, Inc. · 2004

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K033611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033611: Calcigen -Nap Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033611

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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