PEEK Cranial Repair System
Designed for large-scale cranial defect reconstruction. Manufactured from medical-grade PEEK, offering high impact resistance, zero artifact interference during MRI/CT scans, and excellent aesthetic outcome.
Expertise & Manufacturing Capability
High-Precision CMF Fixation & Anatomical Cranial Reconstruction
Ortix Medical Devices Co., Ltd. is an ISO 13485 certified and FDA-registered manufacturer specializing in advanced Craniomaxillofacial (CMF) implants. Our product line encompasses patient-matched PEEK cranial reconstruction systems, ultra-low-profile titanium cranial plates, emergency screws, and specialized transsphenoidal sellar implants designed for neurosurgical and maxillofacial reconstruction.
Engineered to meet rigorous clinical demands, our CMF implants feature superior biocompatibility, optimized anatomical conformability, and seamless intraoperative handling. Every system is supported by precision surgical instrument sets, helping global distributors and hospital procurement buyers achieve consistent quality and fast registration turnover.
Medical Grade PEEK (ASTM F2026)
Radiolucent, thermal insulating, elastic modulus matching cortical bone
Ti-6Al-4V ELI (ASTM F136)
High tensile strength titanium alloy with corrosion-resistant finish
Ultra-Low Profile Design
Plate profile ≤ 0.6mm minimizes soft tissue irritation and palpability
Complete Traceability
100% lot traceability from raw material verification to sterile barrier
Product Portfolio
Standardized & Customized CMF Implants
Explore our core craniomaxillofacial implant systems and complementary neurosurgical instruments engineered for worldwide distribution.
Low Profile Cranial Plating & Screw System
Comprehensive titanium micro-plating solution featuring ultra-thin 0.5mm–0.6mm straight, X, Y, and L-plates alongside 1.5mm / 2.0mm self-drilling and emergency screws for stable cranial flap fixation.
Transsphenoidal Sellar Implant
Specialized reconstruction implant designed specifically for sellar floor closure following transsphenoidal pituitary tumor resection, preventing CSF leakage and protecting intradural structures.
Cranial PEEK Standard Implants
Pre-shaped standardized PEEK plates for temporal, frontal, and parietal cranioplasty applications, providing an immediate off-the-shelf alternative for urgent reconstructive cases.
Burr Hole Covers & Mesh Discs
Low-profile circular burr hole covers engineered to bridge burr hole voids after craniotomy, preventing skin depression and maintaining natural cranial contours.
Self-Drilling & Emergency Cranial Screws
Precision-machined titanium screws with self-drilling flutes for rapid insertion without pre-tapping, available in standard 1.5mm/2.0mm diameters and oversized emergency rescue sizes.
Engineering Precision & Material Science
Ortix Medical Devices Co., Ltd. combines advanced multi-axis CNC milling, high-precision laser marking, and cleanroom packaging to manufacture CMF implants that comply with stringent international regulatory standards.
PEEK Biocompatibility
Conforms to ASTM F2026. Non-allergic, chemically inert, and eliminates cold sensitivity experienced with metal meshes.
Titanium Anodization
Type II anodized surfaces enhance fatigue strength, color-code implant thickness, and minimize tissue adhesion.
3D Anatomical Accuracy
Computer-assisted design (CAD) validation ensures accurate curvature matching human cranial morphology.
Matched Instrumentation
Custom instrument trays equipped with benders, holding forceps, micro-drills, and torque screwdrivers.
Distributor Support & Quality Control
Why Partner with Ortix Medical for CMF Implants
We provide full-spectrum B2B manufacturing services designed to streamline medical device registration and market expansion for regional distributors.
- ISO 13485 & FDA Registration: Ready-to-file technical dossiers (STED) supporting quick local MOH registration.
- Flexible OEM / ODM Services: Private label laser marking, customized plate geometry, and tailored blister packaging layout.
- Low MOQ & Mixed SKU Shipments: Combine PEEK cranial implants, titanium plating, and trauma hardware in single consolidated shipments.
- Dedicated Testing Laboratory: Mechanical pull-out strength, fatigue testing, and dimensional verification reports provided per batch.
Technical Documentation Package Included
Qualified healthcare buyers and distributors can request technical dossiers for tender submission:
- ✓ Raw Material Certificate of Analysis (CoA)
- ✓ Biocompatibility Test Reports (ISO 10993)
- ✓ Sterilization Validation & Shelf-Life Documentation
- ✓ Surgical Technique Guides & IFU Documents
Procurement FAQ
Frequently Asked Questions
Answers to common inquiries from medical device importers and hospital supply managers.
What biocompatible materials are used in Ortix Medical CMF implants?
Ortix Medical utilizes implant-grade PEEK (Polyetheretherketone) complying with ASTM F2026 and Medical Grade Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136 / ISO 5832-3. Both materials offer exceptional biocompatibility, structural stability, and radiolucency options for post-operative CT/MRI imaging.
Do you offer custom PEEK cranial implants based on patient CT scans?
Yes. We support 3D digital CT reconstruction modeling to manufacture customized PEEK cranial implants tailored to specific patient anatomy, alongside our standardized inventory range of plates, meshes, and burr hole covers for immediate distribution.
What quality standards and certifications back Ortix Medical CMF products?
Our manufacturing facility operates under an ISO 13485 certified quality management system and is registered with the U.S. FDA. Every production batch includes complete material test reports (MTR), dimensional inspection certificates, and lot traceability.
Can global distributors order CMF surgical instrument sets with low MOQ?
Yes. Ortix Medical provides complete dedicated surgical instrument kits designed specifically for CMF and cranial repair procedures. We maintain low MOQ policies and support mixed-SKU shipments to assist overseas distributors in expanding their product portfolios.
Request CMF Product Catalog & B2B Wholesale Quote
Partner with Ortix Medical Devices Co., Ltd. for factory-direct pricing, private labeling, and rapid international supply of high-grade CMF implants and surgical tools.
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