510(k) · Cleared
ClearedBiogran Bioactive Glass Synthetic Bone Graft Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita Co. · LYC Bone Grafting Material, Synthetic
Cleared on Dec 19, 1995 after a 176-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 190 later devices descend from it.
- Decided
- Dec 19, 1995
- Review
- 176 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
190 later devices descend from it, 4 citing it directly.
- This deviceK952922 Biogran Bioactive Glass Synthetic Bone Graft MaterialOrthovita Co. · 1995
- Descendant · cites it directly · 158 of its ownK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- Descendant · cites it directly · 85 of its ownK033994 Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · 2 generations on · 84 of its ownK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · 2 generations on · 80 of its ownK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · 3 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
Showing 5 of 190 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 190 · See all- K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996 · cites it directly158descendants
- K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · cites it directly85descendants
- K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on84descendants
- K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on80descendants
- K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 3 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952922 | Biogran Bioactive Glass Synthetic Bone Graft Material | Orthovita Co. | 1995 | — |
| +1 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| +1 | K033994 | Novabone-BBG-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +2 | K041613 | Novabone - AR - Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +2 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +3 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 14 | 0 |
| 2024 | 17 | 0 |
| 2025 | 20 | 0 |
| 2026 | 14 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (190)
See all 1904 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?
- Of its descendants, K962494 (Usbiomaterials Corp., 1996) has gone furthest, with 158 descendants of its own.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K952922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952922: Biogran Bioactive Glass Synthetic Bone Graft Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952922
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026