# K251959: TnR Cranial Implant

- Pathway: 510(k) (Traditional)
- Applicant: T&R BIOFAB CO., Ltd.
- Decided: Jul 30, 2026 after 399 days
- Product code: GXP (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
Longest line of descent: 3 generations back to K013966 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051093: Osteopore PCL Scaffold, Osteopore, Inc. (2006) Summary page 5.

## Indications for use
The TnR Cranial Implant is indicated for use in the repair of neurosurgical burr holes, craniotomy cuts, and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the cranial skeleton.

Source page: https://510kreport.com/device/K251959
Methodology: https://510kreport.com/methodology