# K002063: Biotrace, Model 1730

- Pathway: 510(k) (Traditional)
- Applicant: Bryan Corp.
- Decided: Aug 10, 2000 after 34 days
- Product code: MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041105: Macropore Hydrosorb Spine System (2004), 4 descendants of its own
- K051821: Inion S-1 Biodegradable Anterior Cervical Fusion System (2005), 2 descendants of its own
- K071810: Inion Spinal Graft Containment System (2008), 1 descendant of its own
- K151360: Inion Spinal Graft Containment System (2015), 0 descendants of its own
- K063461: Anova Containment Device (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K002063
Methodology: https://510kreport.com/methodology