510(k) Report

510(k) · Cleared

Cleared

Inion Biorestore

K070998510(k) TraditionalCleared Oct 11, 2007185-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

Inion OY · MQV Filler, Bone Void, Calcium Compound

Cleared on Oct 11, 2007 as substantially equivalent to K000149 (Usbiomaterials Corp., 2000) and 4 other predicates after a 185-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.

Decided
Oct 11, 2007
Review
185 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K960978 (1996). 16 ancestors in all, the oldest K852682 (1985). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor1999: 2 other ancestors1997: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1998: 1 other ancestor1995: 2 other ancestors1985: 1 other ancestor2019: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2015: 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 · 2002K052494 · Novabone-Bioactive Synthetic Graft · Novabone Products, LLC · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K052494 · Novabone-Bioactive Synthetic Graft · Novabone Products, LLC · 2005K021336 · 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
  1. Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
  2. 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
  3. 2 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
  4. 1 generation backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
  5. This deviceK070998 Inion BiorestoreInion OY · 2007
  6. Descendant · cites it directly · 2 of its ownK090177 Inion Biorestore Biodegradable Bone Graft SubstituteInion OY · 2009
  7. Descendant · 2 generations on · 1 of its ownK142463 Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc. · 2014
  8. Descendant · cites it directly · 0 of its ownK191764 Inion BioRestoreInion OY · 2019
  9. Descendant · 3 generations on · 0 of its ownK151876 Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015

Most influential descendants

Showing 4 of 4 · See all
  • K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY · 2009 · cites it directly2descendants
  • K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc. · 2014 · 2 generations on1descendant
  • K191764Inion BioRestoreInion OY · 2019 · cites it directly0descendants
  • K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K960978Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc1996—
−3K980817Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05…Interpore Intl.1998—
−2K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC2002—
−1K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC2005—
0 (this device)K070998Inion BiorestoreInion OY2007—
+1K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY2009—
+2K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.2014—
+1K191764Inion BioRestoreInion OY2019—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199310
199520
199610
199710
199810
199920
200010
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201410
201510
201910
FIG. 1 — Lineage of K070998, 1996–2019Source: 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
*K000149Novabone-Bioglass Bone Graft Particulate
Summary page 1
…Common name: Osteoconductive and osteostimulative bone void filler; Synthetic resorbable bone graft material Regulation number: 888.3045 Predicate devices NovaBone ® (K000149) NovaBone ® Resorbable Bone Graft Substitute (K021336) NovaBone ® Porous Bone Graft Scaffold (K060432) NovaBone ® Resorbable bone…
Usbiomaterials Corp.2000—
*K021336Novabone-Resorbable Bone Graft Substitute
Summary page 1
…e void filler; Synthetic resorbable bone graft material Regulation number: 888.3045 Predicate devices NovaBone ® (K000149) NovaBone ® Resorbable Bone Graft Substitute (K021336) NovaBone ® Porous Bone Graft Scaffold (K060432) NovaBone ® Resorbable bone graft substitute (K052494) PerioGlass ®Bioglass ® Bon…
Novabone Products, LLC2002—
*K060432Novabone Porous-Bone Graft Scaffold
Summary page 1
…aterial Regulation number: 888.3045 Predicate devices NovaBone ® (K000149) NovaBone ® Resorbable Bone Graft Substitute (K021336) NovaBone ® Porous Bone Graft Scaffold (K060432) NovaBone ® Resorbable bone graft substitute (K052494) PerioGlass ®Bioglass ® Bone Graft Particulate (K040278) Conformance with…
Novabone Products, LLC2006—
*K052494Novabone-Bioactive Synthetic Graft
Summary page 1
…s NovaBone ® (K000149) NovaBone ® Resorbable Bone Graft Substitute (K021336) NovaBone ® Porous Bone Graft Scaffold (K060432) NovaBone ® Resorbable bone graft substitute (K052494) PerioGlass ®Bioglass ® Bone Graft Particulate (K040278) Conformance with performance standards No applicable mandatory perform…
Novabone Products, LLC2005—
*K040278Perioglas-Bioglass Bone Graft Substitute
Summary page 1
…Substitute (K021336) NovaBone ® Porous Bone Graft Scaffold (K060432) NovaBone ® Resorbable bone graft substitute (K052494) PerioGlass ®Bioglass ® Bone Graft Particulate (K040278) Conformance with performance standards No applicable mandatory performance standards exist for this device. Compliance to volu…
Novabone Products, LLC2004—

Also cleared against K000149: 7 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092
K191764Inion BioRestoreInion OY20190

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 11 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
  • None of the 16 ancestors has a recall.
  • Of its descendants, K090177 (Inion OY, 2009) has gone furthest, with 2 descendants of its own.
  • 7 other devices also cite its predicate K000149.

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. 2007, 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?

The INION BIORESTORETM implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORETM 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 with bone during the healing process.

Indications for use as stated in the FDA summary.

Also cleared against K000149

7 other devices cite the same predicate.

  • K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc. · 2008
  • K070784Inion BiorestoreInion OY · 2007
  • K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC · 2007
  • K053387Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
  • K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  • K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004

More from Inion OY

14 FDA decisions under this applicant name. See the company

  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025
  • K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY · 2025
  • K203105Inion CompressOn ScrewInion OY · 2021
  • K191764Inion BioRestoreInion OY · 2019
  • K151360Inion Spinal Graft Containment SystemInion OY · 2015

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/K070998 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070998: Inion Biorestore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070998

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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