# K141764: Tristar Bone Graft Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Impladent, Ltd.
- Decided: Dec 18, 2014 after 170 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K761228 (1976). 43 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073342: Salvin Dental Specialties, Inc., Fixation Screw, Salvin Dental Specialties, Inc. (2008) Summary page 4.
- K091812: Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems, Frontier Devices, Inc. (2010) Summary page 4.
- K030806: Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2003) Summary page 4.
- K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1997) Summary page 4.
- K022890: Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2002) Summary page 4.
- K063769: Alpha Bio Bone Fixation Screw System, Alpha-Bio Tec, Ltd. (2007) Summary page 4.
- K021511: Cytoflex Mesh, Unicare Biomedical, Inc. (2002) Summary page 4.

## Most influential descendants
- K170697: GBR system (2018), 2 descendants of its own
- K222367: Save GBR (2023), 0 descendants of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.

Source page: https://510kreport.com/device/K141764
Methodology: https://510kreport.com/methodology