510(k) Report

510(k) · Cleared

Cleared

Inion Biorestore

K070784510(k) TraditionalCleared Jul 24, 2007125-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inion OY · LYC Bone Grafting Material, Synthetic

Cleared on Jul 24, 2007 as substantially equivalent to K000149 (Usbiomaterials Corp., 2000) and 4 other predicates after a 125-day review. Its family tree reaches back 3 generations to 1995.

Decided
Jul 24, 2007
Review
125 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K941780 (1995). 12 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestor1999: 1 other ancestor1993: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor1985: 1 other ancestorK941780 · Orthovita Biogran · Orthovita Co. · 1995K962494 · Perioglas - Bioglass Bone Graft Particulate · Usbiomaterials Corp. · 1996K040278 · Perioglas-Bioglass Bone Graft Substitute · Novabone Products, LLC · 200419851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors K040278 · Perioglas-Bioglass Bone Graft Substitute · Novabone Products, LLC · 2004K962494 · Perioglas - Bioglass Bone Graft Particulate · Usbiomaterials Corp. · 1996K941780 · Orthovita Biogran · Orthovita Co. · 19950
  1. Root · 3 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
  2. 2 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
  3. 1 generation backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
  4. This deviceK070784 Inion BiorestoreInion OY · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K941780Orthovita BiogranOrthovita Co.1995—
−2K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp.1996—
−1K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC2004—
0 (this device)K070784Inion BiorestoreInion OY2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198610
199310
199510
199810
199910
200010
200310
200610
FIG. 1 — Lineage of K070784, 1995–2007Source: 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 LYC? 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 LYC device

  1. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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
…iller; Synthetic resorbable bone graft material Regulation number: 872.3930 Predicate devices NovaBone®0 (KO000149) PerioGlass ® Biog-lass ® Bone Graft Particulate (K040278) Chronos-beta-TCP (K053022)…
Usbiomaterials Corp.2000—
*K040278Perioglas-Bioglass Bone Graft Substitute
Summary page 1
…Regulation number: 872.3930 Predicate devices NovaBone®0 (KO000149) PerioGlass ® Biog-lass ® Bone Graft Particulate (K040278) Chronos-beta-TCP (K053022) Theriridg-eTM Block, Bone Graft Substitute (1(023998) In…
Novabone Products, LLC2004—
*K053022Synthes (Usa) Chronos-Beta-TCP
Summary page 1
…Predicate devices NovaBone®0 (KO000149) PerioGlass ® Biog-lass ® Bone Graft Particulate (K040278) Chronos-beta-TCP (K053022) Theriridg-eTM Block, Bone Graft Substitute (1(023998) Interpore 200 Porous H-ydroxyapatite (1(8609…
Synthes (Usa)2006—
*K023998Theriridge Block, Bone Graft Substitute
Summary page 1
…PerioGlass ® Biog-lass ® Bone Graft Particulate (K040278) Chronos-beta-TCP (K053022) Theriridg-eTM Block, Bone Graft Substitute (1(023998) Interpore 200 Porous H-ydroxyapatite (1(860983) Conformance with performance standards…
Therics, Inc.2003—
*K860983Interpore 200 Porous Hydroxyapatite
Summary page 1
…78) Chronos-beta-TCP (K053022) Theriridg-eTM Block, Bone Graft Substitute (1(023998) Interpore 200 Porous H-ydroxyapatite (1(860983) Conformance with performance standards No applicable mandatory performance standards exist for t…
Interpore Intl.1986—

Also cleared against K000149: 7 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 12 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • None of the 12 ancestors has a recall.
  • 7 other devices also cite its predicate K000149.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, 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
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

What is it indicated for?

The INION BIORESTORETM implants are bone graft substitutes indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; packing into bony voids or gaps to fill and/or augment dental intraosseous, oral and craniomaxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: e.g., periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; and craniofacial augmentation.

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
  • K070998Inion 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 LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K070784 · printed Nov 3, 2026

Cite this page

510(k) Report. “K070784: Inion Biorestore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070784

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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