# K102208: Nanogen

- Pathway: 510(k) (Traditional)
- Applicant: Orthogen, LLC
- Decided: May 6, 2011 after 274 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960978 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011403: Surgiplaster Calcium Sulfate Hemihydrate, Orthogen Corp. (2001) Summary page 1.
- K060285: Bonegen - TR, Bio-Lok Intl., Inc. (2006) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K102208
Methodology: https://510kreport.com/methodology