510(k) · Cleared
ClearedModification to Symphony Graft Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · LYC Bone Grafting Material, Synthetic
Cleared on Mar 1, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it.
- Decided
- Mar 1, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
53 later devices descend from it, 2 citing it directly.
- This deviceK010320 Modification to Symphony Graft Delivery SystemDepuyacromed · 2001
- Descendant · cites it directly · 51 of its ownK022246 Modification to Symphony Graft Delivery SystemDepuyacromed · 2002
- Descendant · 2 generations on · 47 of its ownK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007
- Descendant · 3 generations on · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- Descendant · 4 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- Descendant · 5 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K022246Modification to Symphony Graft Delivery SystemDepuyacromed · 2002 · cites it directly51descendants
- K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc. · 2007 · 2 generations on47descendants
- K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · 3 generations on45descendants
- K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 4 generations on41descendants
- K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 5 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010320 | Modification to Symphony Graft Delivery System | Depuyacromed | 2001 | — |
| +1 | K022246 | Modification to Symphony Graft Delivery System | Depuyacromed | 2002 | — |
| +2 | K072330 | Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System | Biomet, Inc. | 2007 | — |
| +3 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| +4 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| +5 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (53)
See all 532 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, K022246 (Depuyacromed, 2002) has gone furthest, with 51 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/K010320 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010320: Modification to Symphony Graft Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010320
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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