ISO 13485:2016 Certified Manufacturer Dossier

Wholesale Bone Plate Orthoped Pricelist & Technical Quotes

Precision internal fixation systems, locking compression plates (LCP), anatomical reconstruction implants, and direct hospital tender supply structures directly from Beijing ZhongAnTaiHua Technology Co., Ltd. (ZATH).

ASTM F136 Ti-6Al-4V ELI & 316LVM MDR & FDA Registration Ready EO / Gamma Sterile Barrier Packaging Tier-1 Factory Direct Wholesale
Clinical Systems Batch 01

Primary Fixation & Reconstructive Implants Catalog

Explore our verified trauma plates, interlocking assemblies, arthroplasty heads, and endoscopic sets machined under sub-micron CNC tolerances for worldwide surgical distribution.

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Clinical Biomechanics & Metallurgical Engineering

Advanced Osteosynthesis: Locking Compression Plate Dynamics

A comprehensive clinical evaluation of angular stability, periosteal blood flow preservation, and titanium alloy grade selection across high-stress fracture indications.

Angular Stability & Load Transfer

Traditional dynamic compression plates (DCP) rely strictly on plate-to-bone friction, demanding intensive torque that compresses the periosteum and jeopardizes local microvascular perfusion. ZATH's Locking Compression Plate (LCP) family utilizes threaded screw heads that lock into precision-cut combi-holes, forming a rigid fixed-angle construct.

This converts destructive shear stresses into axial and bending forces distributed across the entire plate profile, preventing secondary reduction loss even in severely osteoporotic bone beds.

Medical Titanium ELI vs. 316LVM

Material integrity determines in-vivo fatigue resistance. ZATH utilizes high-purity medical-grade Titanium Grade 5 (Ti-6Al-4V ELI conforming to ASTM F136 / ISO 5832-3) and vacuum-melted surgical stainless steel (ASTM F138 / ISO 5832-1). ELI titanium delivers an optimal modulus of elasticity (~110 GPa), significantly closer to human cortical bone (~18-20 GPa) than stainless steel (~200 GPa).

This substantial reduction in elastic stiffness mitigates stress-shielding osteoporosis while accelerating primary callus formation.

Biological Internal Fixation (BO)

Modern trauma surgery has evolved from rigid mechanical reconstruction toward biological osteosynthesis (BO). Our anatomical contoured plates feature undercuts and tapered profiles that minimize contact area with periosteal osteoblasts.

By eliminating high-pressure plate contact, haversian remodeling remains active, reducing rates of aseptic nonunion, hardware failure, and postoperative infection in complex multi-fragmentary fractures.

Clinical Engineering Insight: "The transition from conventional compression plating to variable-angle locking plates (VAL) has reduced implant displacement rates in intra-articular comminuted fractures by over 41.6% in high-energy trauma registries. Preserving periosteal blood flow through limited-contact undersurface geometries remains the gold standard in reducing delayed unions." — ZATH Technical White Paper (Volume XIV, Orthopedic Biomaterials).

15+
Years Manufacturing Excellence (Since 2009)
±5μm
CNC Swiss Thread Machining Tolerance
100%
Optical CMM & Lot-Traceable Quality Audit
10-6
Sterility Assurance Level (SAL Class 100k)
Direct Factory Sourcing Matrix

Wholesale Bone Plate Orthoped Pricelist & Pricing Models

Structured quotation reference for hospital groups, international distributors, and orthopedic brand owners evaluating FOB, CIF, and OEM volume pricing tiers.

System Category Material Specification Available Configuration MOQ (Pcs) Wholesale Quote Range (USD / Unit) Sterility & Lead Time
Clavicle Locking Plate
Superior, Anterolateral, Hook
Ti-6Al-4V ELI (ASTM F136)
or 316LVM (ASTM F138)
3–10 Holes; Left/Right Anatomical Pre-contoured 20 $22.50 – $38.00 EO Sterile Blister
Stock: 5 Days / Custom: 21 Days
Distal Radius Volar Plate
Variable Angle (VAL) 2.4/2.7mm
Ti-6Al-4V ELI
Sub-micron Anodized
3–9 Shaft Holes; 4–7 Distal Head Screws 20 $26.00 – $44.50 EO Sterile Blister
Stock: 5 Days / Custom: 25 Days
Proximal Humerus (PHILOS-Type)
Multi-planar Polyaxial Screws
Titanium Alloy Grade 5
High Fatigue Limit
3–8 Shaft Holes; Suture Eyelets Integrated 15 $34.00 – $58.00 Sterile / Non-Sterile
Stock: 4 Days / Custom: 20 Days
Distal Femoral Locking Plate
Lateral Condylar Reconstruction
Ti-6Al-4V ELI / Medical SS
Dynamic Wave Profile
5–13 Holes (200mm – 380mm Length) 10 $55.00 – $92.00 Individual Tyvek Pouch
Lead Time: 7–15 Days
Proximal Tibia Locking Plate
Medial & Lateral Column
Ti-6Al-4V ELI
High Yield Strength (>860MPa)
4–14 Holes; Dual-angle Joint Support 10 $48.00 – $84.00 Double Sterile Packed
Lead Time: 7–14 Days
Locking Bone Screws (Cortex/Cancel.)
Ø2.4, Ø2.7, Ø3.5, Ø4.5, Ø5.0mm
Self-Tapping Titanium
Stardrive / Torx Recess
Lengths from 10mm to 95mm (2mm Increments) 100 $2.80 – $6.20 Cleanroom Box / Vial
Instant Stock Dispatch
Cannulated Compression Screws
Headless & Partially Threaded
Titanium Alloy
Continuous Guide Wire Bore
Ø3.0mm, Ø4.5mm, Ø6.5mm, Ø7.3mm 50 $8.50 – $18.00 Single Sterile Tube
Stock: 3–6 Days
Full Orthopedic Instrument Kits
Drill guides, tap, benders, torque driver
Medical Stainless Steel
Custom Autoclave Cases
Trauma Large/Small Fragment Specific 2 Sets $680 – $1,850 Sterilization Container
Immediate Worldwide Cargo

Variable Volume Discounting

Tiered incentives for regional distributors ordering in recurring annual framework contracts: 500+ units achieve an additional 8-12% price rebate; 2,000+ unit consignments qualify for custom anodization laser etching and dedicated inventory safety reserves.

OEM / Private Label Customization

Distributors looking to build independent brand equity can leverage ZATH’s OEM/ODM engineering pipeline: customized packaging boxes, color coded anodizing, laser marking of hospital brand names, and personalized screw caddies.

Transparent Currency Settlement

Support for USD, EUR, RMB, and GBP trade invoicing via Wire Transfer (T/T), Irrevocable Letters of Credit (L/C at sight), and localized clearing accounts to streamline international cross-border medical compliance.

Smart Manufacturing & Industrial IoT

China Factory 4.0: Supply Chain Resilience & Efficiency

How Beijing ZhongAnTaiHua Technology Co., Ltd. (ZATH) transforms raw titanium bar stock into micromachined, sub-micron finished, cleanroom-packaged implants inside Zhongguancun Science Park.

5-Axis Swiss Turn-Mill Centers

Equipped with high-precision imported multi-axis machining centers (Citizen, Star, DMG Mori), our manufacturing floor executes complex bone plate geometries, undercuts, variable-angle combi-holes, and self-tapping screw flute threading in a single automated clamping cycle to eliminate cumulative positioning errors.

Automated Surface Passivation

All titanium trauma implants undergo ultrasonic multi-stage degreasing, electro-chemical de-burring, and Type II anodization. This creates an amorphous, bio-inert titanium dioxide (TiO2) protective layer that drastically curtails heavy metal ion elution while dramatically boosting biocompatibility and osseointegration.

Optical CMM & 100% In-Line Inspection

Critical metrics—such as pitch consistency, core diameter, screw taper angle, plate contour tolerance, and hole thread angle—are verified using computerized 3D coordinate measuring machines (CMM) and laser profile scanners, guaranteeing zero dimensional drift across high-volume production batches.

Class 100,000 Cleanroom Packaging

Implants designated for sterile distribution enter our positive-pressure ISO Class 7 (Class 10,000 / 100,000) cleanroom suites. They are sealed into dual-barrier medical Tyvek blisters validated according to ISO 11607, ensuring complete barrier integrity, puncture resistance, and a confirmed 5-year sterile shelf life.

The Six-Stage Traceable Production Chain

01

Ingot Ingress & Spectrometry

Certified raw titanium and steel bars undergo chemical composition verification and ultrasonic flaw testing before entering the shop floor.

02

Precision Wire EDM Blanking

High-speed submerged wire electrical discharge machining creates anatomical blanks with zero residual thermal deformation or structural grain shifts.

03

Multi-Axis CNC Profiling

Milling under-surfaces, thread cutting, contour chamfering, and locking cone generation at spindle speeds up to 24,000 RPM.

04

Surface Finishing & Anodizing

Automated glass-bead micro-blasting followed by electro-chemical color coding to simplify in-theater surgical identification.

05

Cleanroom Double Blistering

Sterilization packaging in DuPont Tyvek heat-sealed pouches with lot-numbered UDI (Unique Device Identification) barcode labeling.

06

Quarantine & Global Shipping

Controlled environmental warehousing, automated ERP batch reservation, and rapid worldwide transit via DHL/FedEx within 4-6 days.

Macro-Solutions & Global Access

Regulatory Assurance & Hospital Tender Compliance

Solving supply chain friction, navigating stringent medical device regulations (MDR), and maintaining unbeatable healthcare economics amid universal DRG/DIP reimbursement caps.

MDR (EU 2017/745) & ISO 13485 Support

Navigating changing European Medical Device Regulations requires comprehensive technical documentation. ZATH maintains audited ISO 13485:2016 management systems, UDEM certification, and complete technical dossiers.

We furnish local distributor partners with Biocompatibility Test Reports (ISO 10993), Mechanical Static & Dynamic Fatigue Testing Data (ASTM F382 / ISO 9585), Sterilization Validation (ISO 11135 / ISO 11137), and Clinical Evaluation Reports (CER) for prompt national MOH registrations.

DRG / DIP Healthcare Economics

Hospitals worldwide face tightening healthcare budgets under Diagnosis-Related Groups (DRG) and Big Data Diagnosis-Intervention Packaging (DIP). Sourcing implants from traditional Western multinational corporations frequently leaves healthcare providers with unsustainable margins.

ZATH enables distributors and purchasing syndicates to reduce hardware acquisition costs by 45%–60% without compromising biological safety, fatigue life, or precision surgical handling.

Localized Surgical Education & Sets

A successful clinical platform requires synchronized surgical instrumentation. Every ZATH bone plate configuration is backed by dedicated, color-coded, ergonomic orthopedic instrument kits containing depth gauges, sleeve guides, centering drill bits, and calibrated torque limiters.

We supply detailed surgical technique animations, sawbones training materials, and multilingual clinical manuals to ensure immediate operating room adoption by trauma surgeons.

Technological Roadmap & R&D Horizons

The Future of Bone Plating: Next-Gen Horizons (2026–2030)

Anticipating surgical demand through bioactive porous scaffolds, patient-specific 3D titanium additive printing, bioresorbable alloys, and smart sensor telemetry.

Electron Beam Melting (EBM) 3D Printing

ZATH is actively advancing additive manufacturing lines using Selective Laser Melting (SLM) and EBM technologies to fabricate patient-specific oncological reconstruction plates and custom acetabular defect cages featuring controlled trabecular porosity (pore size 450-600 μm) for rapid bone ingrowth.

Biodegradable Magnesium Alloys

To circumvent secondary implant removal procedures—especially in pediatric trauma and small fragment hand/foot osteosynthesis—our R&D division is testing bioresorbable magnesium-calcium-zinc alloys that provide temporary mechanical stabilization while gradually converting into native bone matrix over 12-18 months.

Bioactive Anti-Infection Silver/HA Coatings

In response to open fracture infection challenges, research is advancing physical vapor deposition (PVD) of bactericidal silver-doped hydroxyapatite (Ag-HA) nanocomposite surface coatings. These deliver sustained anti-microbial barrier properties against biofilm formation without local tissue cytotoxicity.

Smart Sensor Strain Telemetry

Future internal fixation systems will incorporate ultra-low-power micro-electro-mechanical system (MEMS) sensors capable of telemetrically reading intra-callus micro-motion, strain deflection, and local mechanical loading to provide real-time objective data on fracture union during rehabilitative weight-bearing.

Procurement Intelligence & Direct Inquiries

Wholesale Bone Plate: Frequently Asked Questions

Direct answers to technical, commercial, quality, and regulatory questions submitted by biomedical engineers, hospital procurement directors, and international distributors.

What are the exact metallurgical specifications for your wholesale titanium bone plates?

ZATH manufactures all titanium bone plate and screw internal fixation systems strictly utilizing medical-grade Titanium Grade 5 ELI (Extra Low Interstitial, Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3). Every raw bar shipment arrives accompanied by full original mill test certificates (MTC) verifying chemical limits for interstitial elements: Carbon ≤ 0.08%, Iron ≤ 0.25%, Oxygen ≤ 0.13%, Nitrogen ≤ 0.05%, Hydrogen ≤ 0.012%. We also offer surgical high-nitrogen stainless steel (316LVM) conforming to ASTM F138 / ISO 5832-1 for cost-sensitive markets.

How are bone plates packed, and what is the validated sterile shelf life?

We supply two standard packing formats: (1) Sterile EO Packaging: Sealed in dual-layer medical DuPont Tyvek pouches inside an ISO Class 7 certified cleanroom, sterilized via Ethylene Oxide (EO) gas with a validated 5-year sterile shelf life (SAL 10^-6), ready for immediate hospital OR deployment; (2) Non-Sterile Bulk Packaging: Protected by individual polyethylene sleeves and protective cardboard cartons designed for distributor-side autoclaving or localized contract gamma radiation.

What documentation do you provide to assist with our national medical device registration?

As an ISO 13485:2016 audited facility in Beijing Zhongguancun Science Park, ZATH supplies authorized distributors with complete Common Technical Dossiers (CTD / STED format). This includes: Notarized Certificate of Free Sale (CFS / FSC), ISO 13485 QMS certificate, UDEM compliance verification, ISO 10993 cytotoxicity, sensitization and systemic toxicity biological reports, ASTM F382 static and dynamic four-point bending fatigue curves, sterilization validation reports (ISO 11135), and clinical literature evaluations.

What is the Minimum Order Quantity (MOQ) and lead time for wholesale purchases?

For standard in-stock inventory items (including clavicle, distal radius, proximal humerus, proximal tibia, and distal femur LCP plates), the MOQ is 10 to 20 units per reference, with shipments dispatched via international express (DHL, FedEx, UPS) within 3 to 6 business days. For customized OEM/ODM projects (custom dimensions, local branding, specific hole geometries, unique anodized colors), our typical prototype run MOQ is 50 to 100 units with an engineered delivery turnaround of 21 to 30 calendar days.

Are ZATH bone plates compatible with standard AO/ASIF surgical instruments?

Yes. The hole architecture, thread pitches, combi-compression slots, and screw head spherical radii of ZATH locking plates are engineered to fully interface with standard international AO/ASIF locking instruments and screwdrivers (Torx / Stardrive, Hexagonal recess). Additionally, ZATH manufactures dedicated, custom-tailored trauma instrument cases, depth gauges, torque-limiting screwdrivers (1.5Nm, 4.0Nm), and drill sleeves to provide seamless intraoperative handling.

What are the exact terms for receiving a formal commercial quote and pricelist?

Distributors and medical procurement departments can submit their required SKU quantities, target metal specification (Titanium ELI or 316LVM Stainless Steel), packaging preference (sterile vs. non-sterile), and destination port via our contact channels. Our commercial engineering desk issues binding formal Proforma Invoices (PI) and FOB/CIF technical price schedules within 24 hours.

Clinical Systems Batch 02

Spine, Extremity & Arthroplasty Complete Product Range

Explore our specialized clavicle hook plates, spinal internal fixation systems, patella clamps, endoscopic columns, and hip arthroplasty instrument cases.

Request Official Bone Plate Wholesale Dossier & Price Catalog

Connect directly with our biomedical engineering staff in Beijing. Evaluate complete product specifications, dimensional blueprints, surgical videos, and customized MOQ contract terms tailored for international orthopedic distribution.