510(k) · Cleared
ClearedOsteon II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoss Co., Ltd. · LYC Bone Grafting Material, Synthetic
Cleared on Jan 17, 2012 as substantially equivalent to K062834 (Genoss Co., Ltd., 2007) after a 120-day review. Its family tree reaches back 6 generations to 1999. 1 later device descends from it.
- Decided
- Jan 17, 2012
- Review
- 120 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K990131 (1999). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 5 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK032268 MBCPBiomatlante · 2003
- 3 generations backK043005 Modification to MBCPBiomatlante · 2005
- 2 generations backK051885 MBCPBiomatlante · 2005
- 1 generation backK062834 Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050Genoss Co., Ltd. · 2007
- This deviceK112716 Osteon IIGenoss Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK251818 Bontree PlusHudens Bio Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251818Bontree PlusHudens Bio Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −5 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K032268 | MBCP | Biomatlante | 2003 | — |
| −3 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −2 | K051885 | MBCP | Biomatlante | 2005 | — |
| −1 | K062834 | Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 | Genoss Co., Ltd. | 2007 | — |
| 0 (this device) | K112716 | Osteon II | Genoss Co., Ltd. | 2012 | — |
| +1 | K251818 | Bontree Plus | Hudens Bio Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062834 | Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050Summary page 1…Proprietary name: OSTEON II Common name: Bone grafting material Classification name: Bone grafting material, Synthetic 3. Predicated Device K062834 OSTEON 4. Description This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapat… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251818 | Bontree Plus | 2026 | 0 |
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 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K251818 (Hudens Bio Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062834.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112716 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112716: Osteon II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112716
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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