510(k) Report

510(k) · Cleared

Cleared

E-Matrix Graft Bone Extender

K083449510(k) TraditionalCleared Jun 12, 2009203-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

Pioneer Surgical Technology · MQV Filler, Bone Void, Calcium Compound

Cleared on Jun 12, 2009 as substantially equivalent to K081558 (Pioneer Surgical Technology, 2008) and 2 other predicates after a 203-day review. Its family tree reaches back 8 generations to 1996.

Decided
Jun 12, 2009
Review
203 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
3

Its longest line of descent runs back 8 generations to K960978 (1996). 31 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2003: 2 other ancestors2006: 1 other ancestor2005: 3 other ancestors2004: 4 other ancestors2002: 4 other ancestors2001: 4 other ancestors2000: 1 other ancestor1999: 1 other ancestor1998: 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. · 1998K000515 · Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, · Interpore Cross Intl. · 2000K012751 · Healos Bone Graft Material · Orquest, Inc. · 2001K043308 · Modification to: Healos Bone Graft Material · Depuy Spine, Inc. · 2005K051386 · Mastergraft Putty Bone Void Filler · Medtronic Vascular · 2005K060917 · Kensey Nash Bone Void Filler · Kensey Nash Corporation · 2006K071187 · Microfuse Bone Void Filler · Globus Medical, Inc. · 20071995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 10 other ancestors4 generations back: 5 other ancestors5 generations back: 1 other ancestor K071187 · Microfuse Bone Void Filler · Globus Medical, Inc. · 2007K060917 · Kensey Nash Bone Void Filler · Kensey Nash Corporation · 2006K051386 · Mastergraft Putty Bone Void Filler · Medtronic Vascular · 2005K043308 · Modification to: Healos Bone Graft Material · Depuy Spine, Inc. · 2005K012751 · Healos Bone Graft Material · Orquest, Inc. · 2001K000515 · Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, · Interpore Cross Intl. · 2000K980817 · 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 · 1996−50
  1. Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 6 generations backK000515 Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051…Interpore Cross Intl. · 2000
  4. 5 generations backK012751 Healos Bone Graft MaterialOrquest, Inc. · 2001
  5. 4 generations backK043308 Modification to: Healos Bone Graft MaterialDepuy Spine, Inc. · 2005
  6. 3 generations backK051386 Mastergraft Putty Bone Void FillerMedtronic Vascular · 2005
  7. 2 generations backK060917 Kensey Nash Bone Void FillerKensey Nash Corporation · 2006
  8. 1 generation backK071187 Microfuse Bone Void FillerGlobus Medical, Inc. · 2007
  9. This deviceK083449 E-Matrix Graft Bone ExtenderPioneer Surgical Technology · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−7K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−6K000515Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101…Interpore Cross Intl.2000—
−5K012751Healos Bone Graft MaterialOrquest, Inc.2001—
−4K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.2005—
−3K051386Mastergraft Putty Bone Void FillerMedtronic Vascular2005—
−2K060917Kensey Nash Bone Void FillerKensey Nash Corporation2006—
−1K071187Microfuse Bone Void FillerGlobus Medical, Inc.2007—
0 (this device)K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200010
200140
200240
200320
200440
200530
200610
200810
FIG. 1 — Lineage of K083449, 1996–2009Source: 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
*K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC
Summary page 2
…2 === 510(k) Summary Pioneer E-Matrix Bone Void Filler Devices to Which Substantial Equivalence is Claimed: K081558 - NanOss Bone Void Filler K032288 - Vitoss Scaffold Foam Bone Graft Material K071187 - MicroFuse Bo…
Pioneer Surgical Technology2008—
*K032288Vitoss Scaffold Foam Bone Graft Material
Summary page 2
…Pioneer E-Matrix Bone Void Filler Devices to Which Substantial Equivalence is Claimed: K081558 - NanOss Bone Void Filler K032288 - Vitoss Scaffold Foam Bone Graft Material K071187 - MicroFuse Bone Void Filler Conclusions: The comparisons and…
Orthovita, Inc.2003—
*K071187Microfuse Bone Void Filler
Summary page 2
…ich Substantial Equivalence is Claimed: K081558 - NanOss Bone Void Filler K032288 - Vitoss Scaffold Foam Bone Graft Material K071187 - MicroFuse Bone Void Filler Conclusions: The comparisons and testing conducted on Pioneer E-Matrix Bone Void Filler demonstrate…
Globus Medical, Inc.2007—

Also cleared against K081558: 2 other devices →

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 13 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
  • 4 of the 31 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K081558.

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. 2009, this device’s year, is highlighted.

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?

Pioneer E-Matrix Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities and pelvis). These defects may be surgically created osseous defects or 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 K081558

2 other devices cite the same predicate.

  • K132470Solum IV Bone Void FillerSpinesmith Partners, Llp · 2014
  • K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology · 2009

More from Pioneer Surgical Technology

50 FDA decisions under this applicant name. See the company

  • K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011
  • K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
  • K101525Pioneer Spinous Process Fusion PlatePioneer Surgical Technology · 2010
  • K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010
  • K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010

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/K083449 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083449: E-Matrix Graft Bone Extender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083449

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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