510(k) · Cleared
ClearedOsteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
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 Apr 24, 2007 as substantially equivalent to K051885 (Biomatlante, 2005) after a 215-day review. Its family tree reaches back 5 generations to 1999. 5 later devices descend from it.
- Decided
- Apr 24, 2007
- Review
- 215 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990131 (1999). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 4 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK032268 MBCPBiomatlante · 2003
- 2 generations backK043005 Modification to MBCPBiomatlante · 2005
- 1 generation backK051885 MBCPBiomatlante · 2005
- This deviceK062834 Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050Genoss Co., Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK112716 Osteon IIGenoss Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK081784 Mastergraft PuttyMedtronic Sofamor Danek · 2008
- Descendant · 2 generations on · 0 of its ownK251818 Bontree PlusHudens Bio Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK140374 Mastergraft PuttyMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK102015 Osteon, Osteon Sinus, Osteon LiftingGenoss Co., Ltd. · 2010
Most influential descendants
Showing 5 of 5 · See all- K112716Osteon IIGenoss Co., Ltd. · 2012 · cites it directly1descendant
- K081784Mastergraft PuttyMedtronic Sofamor Danek · 2008 · cites it directly1descendant
- K251818Bontree PlusHudens Bio Co., Ltd. · 2026 · 2 generations on0descendants
- K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc. · 2014 · 2 generations on0descendants
- K102015Osteon, Osteon Sinus, Osteon LiftingGenoss Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −4 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K032268 | MBCP | Biomatlante | 2003 | — |
| −2 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −1 | K051885 | MBCP | Biomatlante | 2005 | — |
| 0 (this device) | K062834 | Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 | Genoss Co., Ltd. | 2007 | — |
| +1 | K112716 | Osteon II | Genoss Co., Ltd. | 2012 | — |
| +1 | K081784 | Mastergraft Putty | Medtronic Sofamor Danek | 2008 | — |
| +2 | K251818 | Bontree Plus | Hudens Bio Co., Ltd. | 2026 | — |
| +2 | K140374 | Mastergraft Putty | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K102015 | Osteon, Osteon Sinus, Osteon Lifting | Genoss Co., Ltd. | 2010 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K051885 | MBCPSummary page 1…Proprietary Name - OSTEON Common Name - Bone Grafting Material Classification Name - Bone Grafting Material, Synthetic 3. Predicate Device: MBCPTM, Biomatlante, K051885 4. Description: OSTEON is a synthetic resorbable osteoconductive bone graft substitute composed of Hydroxyapatite(HA) and… | 2005 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K112716 (Genoss Co., Ltd., 2012) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K051885.
How does its category compare?
All LYC devicesLYC 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
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 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/K062834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062834: Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062834
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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