510(k) Report

510(k) · Cleared

Cleared

Osteo-G Bone Void Filler System

K031319510(k) TraditionalCleared Jul 17, 200383-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

Aspine USA, Inc. · MQV Filler, Bone Void, Calcium Compound

Cleared on Jul 17, 2003 as substantially equivalent to K010557 (Smith & Nephew, Inc., 2001) and 6 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.

Decided
Jul 17, 2003
Review
83 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K963587 (1997). 8 ancestors in all, the oldest K960978 (1996). 4 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 3 other ancestors1997: 1 other ancestor1996: 1 other ancestor2010: 1 descendant cleared2008: 2 descendants cleared2013: 1 descendant clearedK963587 · Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) · Wrightmedicaltechnologyinc · 1997K991854 · Osteoplast, Model POP200 · Interpore Cross Intl. · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant K991854 · Osteoplast, Model POP200 · Interpore Cross Intl. · 1999K963587 · Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision) · Wrightmedicaltechnologyinc · 19970
  1. Root · 2 generations backK963587 Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc · 1997
  2. 1 generation backK991854 Osteoplast, Model POP200Interpore Cross Intl. · 1999
  3. This deviceK031319 Osteo-G Bone Void Filler SystemAspine USA, Inc. · 2003
  4. Descendant · cites it directly · 1 of its ownK091688 A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010
  5. Descendant · 2 generations on · 0 of its ownK121453 A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013
  6. Descendant · cites it directly · 0 of its ownK072444 Wellgraft PE IGwowei Technology Co., Ltd. · 2008
  7. Descendant · cites it directly · 0 of its ownK072170 Wellgraft PE IIGwowei Technology Co., Ltd. · 2008

Most influential descendants

Showing 4 of 4 · See all
  • K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp. · 2010 · cites it directly1descendant
  • K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp. · 2013 · 2 generations on0descendants
  • K072444Wellgraft PE IGwowei Technology Co., Ltd. · 2008 · cites it directly0descendants
  • K072170Wellgraft PE IIGwowei Technology Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K963587Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)Wrightmedicaltechnologyinc1997—
−1K991854Osteoplast, Model POP200Interpore Cross Intl.1999—
0 (this device)K031319Osteo-G Bone Void Filler SystemAspine USA, Inc.2003—
+1K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp.2010—
+2K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp.2013—
+1K072444Wellgraft PE IGwowei Technology Co., Ltd.2008—
+1K072170Wellgraft PE IIGwowei Technology Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
200130
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201010
201310
FIG. 1 — Lineage of K031319, 1997–2013Source: 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? (7)

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
*K010557Jax Granules Bone Void Filler
Summary page 3
…ly the same. They function by filling voids or gaps in non-load- bearing osseous defects. The predicate devices include the Smith & Nephew JAX Granules Bone Void Filler (K010557) Wright Plaster of Paris Pellets (K963562), the Wright Plaster of Paris Bone Void Filler Kit (K963587), the Osteoset BVF Kit (KO…
Smith & Nephew, Inc.2001—
*K963562Wright Plaster of Paris Pellets
Summary page 3
…s or gaps in non-load- bearing osseous defects. The predicate devices include the Smith & Nephew JAX Granules Bone Void Filler (K010557) Wright Plaster of Paris Pellets (K963562), the Wright Plaster of Paris Bone Void Filler Kit (K963587), the Osteoset BVF Kit (KO 10532), the Interpore Cross Osteoplast Bon…
Wrightmedicaltechnologyinc1997—
*K963587Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision)
Summary page 3
…e devices include the Smith & Nephew JAX Granules Bone Void Filler (K010557) Wright Plaster of Paris Pellets (K963562), the Wright Plaster of Paris Bone Void Filler Kit (K963587), the Osteoset BVF Kit (KO 10532), the Interpore Cross Osteoplast Bone Void Filler (K99 1854), the Biocomposites Ltd. Stirnulan C…
Wrightmedicaltechnologyinc1997—
*K010532Osteoset BVF KitWrightmedicaltechnologyinc2001—
*K991854Osteoplast, Model POP200
Summary page 3
…of Paris Pellets (K963562), the Wright Plaster of Paris Bone Void Filler Kit (K963587), the Osteoset BVF Kit (KO 10532), the Interpore Cross Osteoplast Bone Void Filler (K99 1854), the Biocomposites Ltd. Stirnulan Calcium Sulfate Bone Void Filler Kit (K003954), and the Biomet Orthopedics Calcigen-S Bone Voi…
Interpore Cross Intl.1999—
*K003954Stimulan - Calcium Sulfate Bone Void Filler Kit
Summary page 3
…587), the Osteoset BVF Kit (KO 10532), the Interpore Cross Osteoplast Bone Void Filler (K99 1854), the Biocomposites Ltd. Stirnulan Calcium Sulfate Bone Void Filler Kit (K003954), and the Biomet Orthopedics Calcigen-S Bone Void Filler (K013790). All of these devices are intended to fill osseous voids or ga…
Biocomposites, Ltd.2001—
*K013790Calcigen-S Bone Void Filer
Summary page 3
…ast Bone Void Filler (K99 1854), the Biocomposites Ltd. Stirnulan Calcium Sulfate Bone Void Filler Kit (K003954), and the Biomet Orthopedics Calcigen-S Bone Void Filler (K013790). All of these devices are intended to fill osseous voids or gaps and consist of calcium sulfate.…
Biomet Orthopedics, Inc.2002—

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp.20101
K072444Wellgraft PE IGwowei Technology Co., Ltd.20080
K072170Wellgraft PE IIGwowei Technology Co., Ltd.20080

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 6 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K091688 (Ag Digital Technology Corp., 2010) has gone furthest, with 1 descendant 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—

What is it indicated for?

The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony vloids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.

Indications for use as stated in the FDA summary.

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/K031319 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031319: Osteo-G Bone Void Filler System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031319

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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