Locking Plate System Pelvic Manufacturer & Factory

Precision-Engineered Trauma Reconstruction Implants & Class III Medical Device Solutions

Featured Pelvic & Spinal Implants

Engineered to meet the stringent requirements of trauma reconstruction, spinal fixation, and anatomical joint alignment.

Pelvic Locking Plate
Pelvic System

Fule Orthopedic Surgical Implants Pelvic Locking Plate Titanium Straight and Arc-Shaped Reconstruction Plate Class III

View Details
Anterior Cervical Plate
Spine Trauma

Anterior Cervical Plate and Variable Angle Screw for Spine Trauma Implant Titanium Alloy Material Pedicle Spine Implants

View Details
Posterior Spinal System
Spinal Fixation

Beijing Fule Occipitocervical Thoracic Posterior Spinal Screw-Rod System Model CFS Made of Durable Titanium and Titanium Alloy

View Details
Usmart Spine System
Implantable OEM

Usmart Titanium Spinal Screw-Rod System CE/ISO13485/ISO9001 Certified Class III 5+ Year Warranty Spine Surgery Implantable OEM

View Details
MIS TLIF Instruments
Surgical Instruments

CE Posterior Orthopedic MIS TLIF Instruments Instruments From Beijing Fule

View Details
Lumbar Fusion Cage
Spine Fusion

CE Marked Fule Brand High Quality Class I Medical Instruments Posterior Lumbar Interbody Fusion Cage Spine Surgery 1 Year

View Details
Screw Removal Instruments
Trauma Instruments

Hot-selling Broken Screws Removal Instruments Set From Beijing Fule

View Details
Medical Pedicle Screw
Osteoporosis System

DHL Titanium Fedex Customized Medical Screw COX II Bone Cement Pedicle Screw 6.0 System for the Treatment of Osteoporosis

View Details

Evolution of Pelvic & Acetabular Fixation Systems

The biomechanical complexities of pelvic fractures require implant systems designed to balance high stiffness with anatomical contouring.

Pelvic ring disruptions and acetabular fractures rank among the most biomechanically challenging injuries managed by trauma surgeons. Unlike long bones, the pelvis functions as a load-bearing arch that distributes massive vertical forces from the axial skeleton to the lower extremities. Consequently, any stabilization system must resist complex multiplanar loads, including shear, compression, and torsion forces.

The clinical adoption of the Locking Plate System for Pelvic Fractures represents a significant paradigm shift. Conventional plating relies on the friction interface between the plate and bone surface, which often risks secondary loss of reduction, screw toggle, and construct failure—particularly in osteoporotic bone. In contrast, locked plating acts as a fixed-angle construct, transferring loads directly from the bone, through the locking screws, to the plate. This mechanism prevents screw pullout and limits localized stress concentration.

Strategic Information Gain: Minimizing Soft Tissue Devitalization

Modern pelvic trauma reconstruction emphasizes minimal implant profiles and anatomical pre-contouring. Traditional systems often demanded extensive intraoperative bending, which could compromise the mechanical integrity of the titanium alloy and increase operating times. Today’s state-of-the-art designs feature pre-shaped geometries matching the complex curves of the iliopectineal line, pubic symphysis, and posterior iliac column, drastically reducing tissue disruption and preventing implant-associated soft-tissue irritation.

Clinical trends are increasingly favoring polyaxial locking technologies. Standard monaxial locking systems restrict screw insertion to predefined trajectories. In acetabular fractures, however, vital neurovascular structures and the joint space restrict screw path choices. Polyaxial locking allows up to 20-30 degrees of angular deviation, enabling surgeons to target secure, high-density bone blocks while safely bypassing articular cartiledge and vascular bundles.

Anatomical Pre-contouring

Optimized for the complex curves of the male and female pelvic rings, reducing intraoperative preparation time.

Biocompatible Grade 5 Ti

Constructed with Ti-6Al-4V ELI (Extra Low Interstitial) for exceptional fatigue limit and rapid osseointegration.

Global Sourcing & Supply Chain Resiliency

Understanding regulatory requirements, delivery frameworks, and precision demands for international orthopedic markets.

30+
Years Industry Experience
10,000㎡
Advanced Manufacturing Area
102
Precision Production Machines
511K
Annual Unit Output Capacity

Global Purchasing Standards & Demands

International distributors, hospital systems, and procurement agents seek more than just low-cost manufacturing. In the medical sector, risk mitigation is paramount. Orthopedic implants operate under high-risk regulatory classes (such as EU MDR Class III and FDA Class III). A reliable manufacturing partner must supply robust documentation, including ISO 13485 certification, material analysis test reports, and fully traceable manufacturing histories.

Our export network spans Eastern Europe, Southeast Asia, and domestic markets, delivering solutions tailored to distinct regional requirements. In Eastern Europe, compliance with stringent CE standards is mandatory. In Southeast Asia, partners prioritize cost-efficient logistics, durable packaging, and modular instrument configurations. To address these needs, we maintain partnerships with over 70 supply chain entities, ensuring stable raw material sourcing and smooth shipping operations.

China Factory 4.0: Modern Manufacturing

Our facility integrates advanced Factory 4.0 paradigms. With 102 precision manufacturing machines, including 5-axis CNC machining centers and high-speed Swiss milling stations, we process complex curved contours within tolerance limits under +/- 5 microns. This level of precision is crucial for pelvic reconstructive plates, where minor dimensional deviations can lead to improper fit or local implant loosening.

We manage every step of production, from raw titanium rods to final chemical cleaning and sterile-ready packaging, through a single continuous process. Under the guidance of our 20-engineer R&D department (featuring 15 graduate professionals), we routinely develop and test customized designs, launching over 20 new products annually.

Manufacturing Capabilities & Technical Profile

A statistical breakdown of our operations, quality standards, and export capacity.

Fule Orthopedics - Registered June 28, 1996

ISO 13485 CERTIFIED
Factory & Production Setup
Floor Space
10,000 Square Meters
Active Machinery
102 Advanced Production Units
Annual Capacity
511,000 Finished Units / Year
Quality Management System (QMS)
Traceability
Yes (Raw Material to Finished Goods)
Inspection Process
100% Inspection on All Production Lines
QC Inspectors
15 Dedicated On-Site QA/QC Specialists
Research & Customization Solutions
R&D Team Profile
20 Engineers (15 Graduates / 5 Junior College)
Customization Options
Sample Processing, Graphic Processing, Demand Customization
New Product Launches
20 New Systems Developed Annually
Global Market Distribution
Domestic (China)
40%
Eastern Europe
15%
Southeast Asia
10%

Advanced Production Facility & Quality Control

A photographic tour of our manufacturing floors, cleanrooms, testing labs, and state-of-the-art logistics setups.

Localized Applications of the Pelvic Plating System

Custom configurations designed for specific trauma surgery scenarios and orthopedic repair processes.

Anterior Pelvic Ring Repair

Indicated for diastasis of the pubic symphysis. Pre-contoured locking plates provide the stability needed to withstand lateral shear and compression, allowing early patient mobilization and preventing long-term malalignment.

Acetabular Column Reconstruction

Reconstructive plates are shaped to follow the curve of the acetabular dome. When combined with locking screws, they prevent articular surface displacement, reducing the incidence of post-traumatic osteoarthritis.

Posterior Sacroiliac Fixation

Used for posterior pelvic disruptions where structural loads are highest. Rigid, multi-screw configurations bridge the joint space to stabilize the posterior column against dynamic shear forces.

Technical & Purchasing Q&A

In-depth responses to regulatory, engineering, and manufacturing questions for medical device procurement.

Q1: What titanium grades are used in the Pelvic Locking Plate systems?
Our pelvic locking plates and screws are manufactured using high-grade Ti-6Al-4V ELI (Grade 5, ASTM F136). This alloy provides exceptional biocompatibility, high fatigue strength under cyclic loads, and a lower modulus of elasticity compared to stainless steel, which helps reduce bone stress shielding.
Q2: How does the factory manage quality control and raw material traceability?
We follow strict ISO 13485 standards. Our QMS operates with 15 quality inspectors who perform 100% inspections across all production lines. Each batch of raw titanium has full chemical and physical test records, and every implant is laser-marked with a unique batch number for complete tracking from materials to the clinic.
Q3: Can plates be modified or custom-molded to fit custom surgical preferences?
Yes, our R&D department specializes in custom designs. We offer customization options including graphic-based design, sample processing, and tailored profile parameters. Our team of 20 engineering experts uses advanced 3D CAD/CAM models to transition from mock-ups to functional clinical prototypes.
Q4: What is the typical lead time for global OEM/ODM orders?
For standard products, order processing takes approximately 15 to 30 days, depending on inventory levels and production schedules. Large-scale OEM orders requiring customized tooling typically require 45 to 60 days. Our logistics network coordinates with international shippers to ensure timely customs clearance and delivery.
Q5: Do you provide corresponding surgical instrumentation sets?
Yes. We supply dedicated, sterile-ready instrumentation sets (drill bits, depth gauges, torque limiters, and plate benders) designed for each system, ensuring seamless integration and reliable performance in the operating room.

Advanced Spine & Trauma Fixation Portfolio

Additional clinical products manufactured to the same rigorous standards as our pelvic systems.

Posterior Cervical Fixation
Spinal Fixation

China Manufacture High Quality Titanium Orthopedic Implant CFS ZJX Posterior Cervical Spinal Fixation System OEM Fule Brand CE

View Details
PKP Working Channel
Vertebral Instruments

PKP Working Channel Vertebral Body Instruments the Basis of Surgical Instruments for Orthopedic Surgery Class I

View Details
Posterior Cervical Laminoplasty
Spine Surgery

Hot Sales Titanium Posterior Cervical Laminoplasty Spine Surgery Orthopedic Implant CE Certified

View Details
Spine Fixation Box
Instrument Containers

Spine Fixation Spinal Screw Box Orthopedic Instruments Surgical Tools

View Details
Implant Set
Posterior Spine

Fule Brand CE Certified Orthopedic Surgery Titanium Alloy Implant Set Medical Plate Laminiplasty for Posterior Spine Surgery

View Details
PFNA Intramedullary Nail
Trauma Nails

Competitive Price CE Marked Metal PFNA Femoral and Reconstructional Intramedullary Nail for Trauma Surgery

View Details
Hand & Foot Locking Plates
Extremities

CE Marked Titanium Full Hand & Foot Locking Plates Competitive Price for Secure Fixation

View Details
Anterior Cervical Plate
Spinal Trauma

Anterior Cervical Plate 4 Hole Spine Titanium Orthopedic Implants Pedical Screw Rod Implant

View Details
All Pelvic Products