510(k) · Cleared
ClearedNanogen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthogen, LLC · LYC Bone Grafting Material, Synthetic
Cleared on May 6, 2011 as substantially equivalent to K011403 (Orthogen Corp., 2001) and 1 other predicate after a 274-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- May 6, 2011
- Review
- 274 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960978 (1996). 10 ancestors in all, the oldest K955096 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK030288 Polygraft Bone Graft SubstituteOsteobiologics, Inc. · 2003
- 1 generation backK060285 Bonegen - TRBio-Lok Intl., Inc. · 2006
- This deviceK102208 NanogenOrthogen, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K030288 | Polygraft Bone Graft Substitute | Osteobiologics, Inc. | 2003 | — |
| −1 | K060285 | Bonegen - TR | Bio-Lok Intl., Inc. | 2006 | — |
| 0 (this device) | K102208 | Nanogen | Orthogen, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K011403 | Surgiplaster Calcium Sulfate HemihydrateSummary page 1…noGen (Nanocrystalline calcium sulfate particles) COMMON NAME: Hone filling augmentation material SUBSTANTIALLY EQUIVALENT TO: SurgiPlaster K 011403, BoneGen-TR K 060285 DESCRIPTION of the DEVICE: NanoGen is a mixture of particles composed of densely packed grains of nanocrys… | 2001 |
| * | K060285 | Bonegen - TRSummary page 1…e calcium sulfate particles) COMMON NAME: Hone filling augmentation material SUBSTANTIALLY EQUIVALENT TO: SurgiPlaster K 011403, BoneGen-TR K 060285 DESCRIPTION of the DEVICE: NanoGen is a mixture of particles composed of densely packed grains of nanocrystalline calcium sulfa… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K011403.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
1. By itself in bone regenerative techniques;
2. Mixed with other suitable bone filling agents to prevent particle migration in an osseous defect; and,
3. To provide a resorbable barrier over other bone graft materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102208: Nanogen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102208
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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