510(k) Report

510(k) · Cleared

Cleared

Nanoss Bone Void Filler

K050025510(k) TraditionalCleared Feb 3, 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

Angstrom Medica, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Feb 3, 2005 as substantially equivalent to K011531 (Biomet, Inc., 2002) and 4 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1996. 11 later devices descend from it.

Decided
Feb 3, 2005
Review
28 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K960978 (1996). 8 ancestors in all. 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor2008: 1 descendant cleared2014: 3 descendants cleared2009: 2 descendants cleared2011: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedK960978 · 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. · 1998K021336 · Novabone-Resorbable Bone Graft Substitute · Novabone Products, LLC · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants K021336 · Novabone-Resorbable Bone Graft Substitute · Novabone Products, LLC · 2002K980817 · 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+5
  1. Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 1 generation backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
  4. This deviceK050025 Nanoss Bone Void FillerAngstrom Medica, Inc. · 2005
  5. Descendant · cites it directly · 10 of its ownK081558 Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology · 2008
  6. Descendant · 2 generations on · 7 of its ownK091031 Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009
  7. Descendant · 3 generations on · 4 of its ownK110561 Fortross Bone Void FillerPioneer Surgical Technology · 2011
  8. Descendant · 4 generations on · 3 of its ownK141600 Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive…Pioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
  9. Descendant · 5 generations on · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22011: 22014: 32017: 12024: 12025: 1
2008high 3 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all
  • K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology · 2008 · cites it directly10descendants
  • 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
−3K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−2K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−1K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC2002—
0 (this device)K050025Nanoss Bone Void FillerAngstrom Medica, Inc.2005—
+1K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology2008—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200010
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201120
201430
201710
202410
202510
FIG. 1 — Lineage of K050025, 1996–2025Source: 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? (5)

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
*K011531Calcium Phosphate Granular Bone Void FillerBiomet, Inc.2002—
*K021336Novabone-Resorbable Bone Graft Substitute
Summary page 2
…icate devices are substantially the same. These devices include Biomet Calcium Phosphate Granular Bone Void Filler (KOI 1531); NovaBone Resorbable Bone Graft Substitute (K021336); Wright Medical Technology Osteoset Resorbable Mini Bead Kit (K010532); Orthovita Vitoss Scaffold (K994337) and Interpore Pro Os…
Novabone Products, LLC2002—
*K010532Osteoset BVF Kit
Summary page 2
…Calcium Phosphate Granular Bone Void Filler (KOI 1531); NovaBone Resorbable Bone Graft Substitute (K021336); Wright Medical Technology Osteoset Resorbable Mini Bead Kit (K010532); Orthovita Vitoss Scaffold (K994337) and Interpore Pro Osteon 50OR (K99013 1). These devices all are intended to fill voids or g…
Wrightmedicaltechnologyinc2001—
*K994337Vitoss Scaffold Synthetic Cancellous Bone Void Filler
Summary page 2
…Filler (KOI 1531); NovaBone Resorbable Bone Graft Substitute (K021336); Wright Medical Technology Osteoset Resorbable Mini Bead Kit (K010532); Orthovita Vitoss Scaffold (K994337) and Interpore Pro Osteon 50OR (K99013 1). These devices all are intended to fill voids or gaps in osseous defects, are not inten…
Orthovita Co.2000—
*K990131Pro Osteon Implant 500R Resorbable Bone Graft Substitute
Summary page 2
…one Graft Substitute (K021336); Wright Medical Technology Osteoset Resorbable Mini Bead Kit (K010532); Orthovita Vitoss Scaffold (K994337) and Interpore Pro Osteon 50OR (K99013 1). These devices all are intended to fill voids or gaps in osseous defects, are not intended to be load-bearing and consist of a v…
Interpore Cross Intl.1999—

Also cleared against K011531: 1 other device →

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810

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 9 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K081558 (Pioneer Surgical Technology, 2008) has gone furthest, with 10 descendants of its own.
  • 1 other device also cites its predicate K011531.

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?

NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product is indicated to be gently packed into 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 traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Indications for use as stated in the FDA summary.

Also cleared against K011531

1 other device cites the same predicate.

  • K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc. · 2003

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/K050025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050025: Nanoss 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/K050025

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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