Fusion Craniofacial Implant; Fusion Skull Implant

The Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are patient-specific prosthetic plates designed to fill bony voids or defects in the cranial and craniofacial skeleton. Each implant is custom-sized and shaped using CT scan data, ranges from 2-10 mm thick, and is fabricated from PEEK material formulated with biphasic calcium phosphate (BCP PEEK). The devices are provided non-sterile for steam sterilization prior to implantation and are secured to native bone using commercially available cranioplasty hardware.

The subject device differs from predicate devices (K103582, K121755, K182711) primarily in the base material composition: it uses Evonik Vestakeep iC4800R® (BCP PEEK formulation) versus the predicates' Evonik Vestakeep i4® or Invibio PEEK-Optima LT-1®. The new material is intended to facilitate enhanced bone ingrowth. All other technological elements—custom sizing via CT scan, non-sterile provision, fixation method, and product classification—remain identical to the predicate devices.

Testing was conducted per ISO 10993 series biocompatibility standards (genotoxicity, cytotoxicity, implantation effects, sensitization, irritation, acute and subchronic toxicity), ANSI/AAMI ST79 for steam sterilization validation, and USP Class VI testing. A company-developed Mechanical Testing Validation Protocol was used for non-load bearing prosthetic plates (noting no industry consensus standard exists). Cleaning validation, bacterial endotoxin testing, and ship testing validation were also performed.

The subject devices are substantially equivalent because they maintain identical indications for use, intended patient population, design methodology, manufacturing process, sterilization approach, and fixation method as the predicate devices. The material change from standard PEEK to BCP PEEK is not a fundamental technological departure but rather a formulation enhancement designed to improve bone ingrowth without introducing new safety or effectiveness concerns. Comprehensive biocompatibility testing on the new material confirms no deleterious effects, and mechanical testing demonstrates equivalent performance to predicates under worst-case scenarios.