510(k) · Cleared
ClearedOrthovita Biogran
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 Feb 10, 1995 after a 301-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 159 later devices descend from it.
- Decided
- Feb 10, 1995
- Review
- 301 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
159 later devices descend from it, 1 citing it directly.
- This deviceK941780 Orthovita BiogranOrthovita Co. · 1995
- Descendant · cites it directly · 158 of its ownK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- Descendant · 2 generations on · 85 of its ownK033994 Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · 3 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 · 4 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
Showing 5 of 159 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 159 · See all- K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996 · cites it directly158descendants
- K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on85descendants
- K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · 3 generations on84descendants
- K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on80descendants
- K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| +1 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| +2 | K033994 | Novabone-BBG-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +3 | K041613 | Novabone - AR - Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +2 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +4 | 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 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 12 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (159)
See all 1591 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962494 | Perioglas - Bioglass Bone Graft Particulate | 1996 | 158 |
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/K941780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941780: Orthovita Biogran.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941780
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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