A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.

Summary

This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.

Conditions

• Tumor
• Facial Fracture
• Mandibular Fractures
• Fibrous Dysplasia
• Osteoma of Mandibular Condyle
• Neuroma
• Cleft Face
• Hemifacial Microsomia
• Treacher Collins Syndrome
• Miller Syndrome
• Nager Syndrome

Interventions

DEVICE

Titanium Facial Plates

The Facial Plating System provides a comprehensive titanium fixation solution for maxillofacial surgery procedures. More than twenty-five different plating options in two systems, the 1.5 mm and 2.0 mm with a variety of instruments, and high torque screws, including meshes, are part of this system. Plates and screws are made of commercially pure titanium per ASTM F-67, Titanium 6Al 4V Alloy per ASTM F-136.

DEVICE

Titanium Mandibular Plates

The Mandibular Plating System provides a comprehensive titanium fixation solution for mandibular surgical procedures. Several plating options, a variety of instruments, and high torque screws with various plate shapes are part of this system. Plates in the Mandibular Plating System have profiles of various thicknesses. Screws are available in self-tapping, locking and non-locking varieties, and in various sizes between 2.0 mm and 2.3 mm in diameter, and 5 mm to 18 mm in length.

DEVICE

Add-on Condyle

The Add-On Condyle is intended to be implanted in the human jaw to replace the mandibular condyle to functionally reconstruct the temporomandibular joint on a temporary basis for patients undergoing ablative tumor surgery requiring the removal of the native mandibular condyle. This device is not for permanent implantation, traumatic injuries, or for treatment of temporomandibular joint disease.

DEVICE

HTR-PEKK

The HTR-PEKK implants are fabricated from polyether-ketone-ketone (PEKK) via selective laser sintering (SLS), a 3D manufacturing technique. The laser sintering machine builds the implant in layers as dictated from a stereolithographic (STL) file of the approved implant. The HTR-PEKK implants are designed individually for each patient to replace bony voids in the facial anatomy using a patient's own CT imaging data. The implant is made to fill an existing or planned void (where appropriate) using computer-aided design technology for anatomy enhancement, correction of trauma injuries, and/or to correct congenital defects in the craniofacial bone.

Sponsors & Collaborators

• Zimmer Biomet

  lead INDUSTRY

Principal Investigators

• Mark Sun, PhD · Zimmer Biomet

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2023-09-01

Completion

2023-11-30

FDA Device

Yes

Countries

• Argentina

Study Locations