510(k) Report

510(k) · Cleared

Cleared

Calcium Phosphate Granular Bone Void Filler

K011531510(k) TraditionalCleared Sep 6, 2002477-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 Sep 6, 2002 after a 477-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Sep 6, 2002
Review
477 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 2 descendants cleared2005: 2 descendants cleared2008: 1 descendant cleared2007: 1 descendant cleared2014: 3 descendants cleared2009: 2 descendants cleared2011: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK011531 Calcium Phosphate Granular Bone Void FillerBiomet, Inc. · 2002
  2. Descendant · cites it directly · 11 of its ownK050025 Nanoss Bone Void FillerAngstrom Medica, Inc. · 2005
  3. Descendant · 2 generations on · 10 of its ownK081558 Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology · 2008
  4. Descendant · 3 generations on · 7 of its ownK091031 Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009
  5. Descendant · 4 generations on · 4 of its ownK110561 Fortross Bone Void FillerPioneer Surgical Technology · 2011
  6. Descendant · 5 generations on · 3 of its ownK141600 Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive…Pioneer Surgical Technology, Inc. (Rti Surgical, I · 2014

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2003: 22005: 22007: 12008: 12009: 22011: 22014: 32017: 12024: 12025: 1
2003high 3 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 16 · See all
  • K050025Nanoss Bone Void FillerAngstrom Medica, Inc. · 2005 · cites it directly11descendants
  • K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology · 2008 · 2 generations on10descendants
  • K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009 · 3 generations on7descendants
  • K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011 · 4 generations on4descendants
  • K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011531Calcium Phosphate Granular Bone Void FillerBiomet, Inc.2002—
+1K050025Nanoss Bone Void FillerAngstrom Medica, Inc.2005—
+2K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology2008—
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology2009—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology2011—
+5K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200520
200710
200810
200920
201120
201430
201710
202410
202510
FIG. 1 — Lineage of K011531, 2002–2025Source: 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), 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? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511
K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.20033

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, K050025 (Angstrom Medica, Inc., 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—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

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  • 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/K011531 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011531: Calcium Phosphate Granular 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/K011531

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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