# K123633: TRS Cranial Bone Void Filler (TRS C-BVF)

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regeneration Systems, Inc.
- Decided: Aug 16, 2013 after 266 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 2.
- K071046: Synthes Chronos Composite, Synthes (Usa) (2007) Summary page 2.
- K041350: Synthes (Usa) Chronos, Synthes (Usa) (2004) Summary page 2.
- K041611: Synthes (Usa) Rapid Resorbable Cranial Clamp, Synthes (Usa) (2004) Summary page 2.

## Indications for use
TRS C-BVF is intended for use in the repair of 13 mm neurosurgical cranial burr holes. It should be gently packed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.

Source page: https://510kreport.com/device/K123633
Methodology: https://510kreport.com/methodology