What orthopedic product lines does ZATH manufacture?

ZATH manufactures five platforms: joint replacement (hip and knee), spine (pedicle screw, MIS, anterior cervical plate, fusion cage and vertebroplasty), trauma (locking plates, intramedullary nails, cannulated screws, external fixation, pin and cable), sports medicine (suture anchors, buttons, staples) and matching surgical instrument sets.

Is ZATH certified to ISO 13485?

Yes. ZATH operates an ISO 13485-certified quality management system covering design, manufacturing, inspection, sterilization packaging and storage. Certificate copies are available to qualified distributors on request.

Are ZATH implants supplied sterile?

All ZATH implant series are available in sterile packaging, which helps hospitals shorten operating room preparation time and supports infection control protocols.

Does ZATH support OEM and ODM orders?

Yes. Logo, size range, appearance, colour and packaging can be customized to distributor and regional registration requirements.

How fast is international delivery?

Express shipments are dispatched via DHL, FedEx, TNT, UPS or EMS, typically arriving within 4 to 6 days depending on destination and customs clearance.

ISO 13485:2016 Certified Orthopedic Manufacturer

Best Orthopedic Implant Screw Manufacturer & B2B Pricelist

Global OEM/ODM Titanium & Stainless Steel Osteosynthesis Screws: Medical Device Engineering Whitepaper, ASTM F543 Biomechanical Conformance, and Direct-from-Factory Strategic Sourcing.

Precision Portfolio Showcase I

Featured Implant Platforms & Surgical Sets

Directly machined to micron-level tolerances under ISO 13485 cleanroom protocols. Engineered for seamless bicortical engagement, optimal pullout resistance, and minimal bone-screw stress concentrations.

Arthroplasty High-Quality Hip Joint Replacement Universal Instrument Set (Acetabular Part)

High-Quality Hip Joint Replacement Universal Instrument Set (Acetabular Part)

Explore Specifications

Sports Med OEM SuperFix Titanium Endo Button With Loop Surgical Operations

OEM SuperFix Titanium Endo Button With Loop Surgical Operations

Explore Specifications

Trauma Fixation Discount MASTIN Expert Tibial Intramedullary Nail Instrument Set

Discount MASTIN Expert Tibial Intramedullary Nail Instrument Set

Explore Specifications

Reconstruction ODM AC Joint Reconstruction Instrument Set

ODM AC Joint Reconstruction Instrument Set

Explore Specifications

Diagnostics ODM Non-invasive Ladder Optical Coherence Tomography System

ODM Non-invasive Ladder Optical Coherence Tomography System

Explore Specifications

LCP System OEM Proximal Lateral Tibia Locking Compression Plate

OEM Proximal Lateral Tibia Locking Compression Plate

Explore Specifications

Spine Systems Best Zipper 6.0 System Spinal Internal Fixation System Instrument Set

Best Zipper 6.0 System Spinal Internal Fixation System Universal Set

Explore Specifications

Bone Screws OEM 2.0mm 2.7mm 3.5mm 5.0mm Locking Screw Orthopedic Screw Implants

OEM 2.0mm 2.7mm 3.5mm 5.0mm Locking Screw Orthopedic Implants

Explore Specifications

Industry Macro Intelligence

Global Orthopedic Screw Dynamics: Engineering Meets Value Care

As health systems transition toward Outpatient Surgery Centers (ASCs), bundled reimbursement models, and stringent European MDR (Regulation EU 2017/745), the procurement of internal fixation hardware has shifted from legacy brand dominance to audited manufacturing accountability.

Sub-Micron Thread Geometries & Pullout Dynamics

Modern clinical consensus favors dual-lead, buttress, and reverse-cutting flutes. Cortical screws demand shallower thread depths to maximize core diameter and shear modulus, whereas cancellous variants utilize broad pitch angles (up to 2.75mm pitch) to compact osteoporotic trabeculae without causing micro-fracturing during insertion.

MDR & VBP Cost-Containment Pressures

Distributors across Western Europe, Latin America, and Southeast Asia face severe margin compression caused by national Volume-Based Procurement (VBP) mandates and MDR recertification overhead. Direct engagement with verified tier-1 Asian manufacturers mitigates redundant distribution markups without sacrificing biological safety.

Cleanroom Ready-to-Implant Paradigm

Autoclaving implant trays in hospital central sterile supply departments (CSSD) introduces variable human error, washer residues, and cross-contamination risks. Worldwide demand is shifting decisively to pre-packaged, sterile peel-pack blister assemblies under ISO 11607 protocols with 5-year accelerated aging shelf life.

Material Science & Biomechanics

Engineering Rigor: ASTM F543 Compliance & Metallurgical Purity

Orthopedic screws must withstand extreme cyclic axial and torsional forces during initial fracture reduction until primary osseous bridging occurs. At Beijing ZhongAnTaiHua Technology Co., Ltd. (ZATH), material integrity is validated from raw titanium billets to final anodic oxidation.

Ti-6Al-4V ELI (ASTM F136 / ISO 5832-3)

Extra Low Interstitial (ELI) Grade 5 titanium offers superior fatigue strength and a lower elastic modulus (approximately 110 GPa) relative to stainless steel, substantially diminishing the risk of stress shielding in peri-implant cortical bone. The formation of a dense, self-healing titanium oxide ($TiO_2$) passivated layer provides exceptional biocompatibility, negligible ion leaching, and artifacts-reduced MRI imaging compatibility.

Tensile: ≥ 860 MPa Yield: ≥ 795 MPa Elongation: ≥ 10% ISO 5832-3 Certified

Medical Grade 316LVM (ASTM F138 / ISO 5832-1)

Vacuum Arc Remelted (VAR) austenitic stainless steel provides exceptional ductile plasticity and maximum shear resistance, making it the preferred alloy for high-stress load-bearing trauma constructs and heavy fragment stabilization. Rigorous control of inclusions (non-metallic sulfur and phosphorus < 0.010%) prevents localized pitting or crevice corrosion inside the internal hex or star recess under physiological saline environments.

High Shear Modulus Vacuum Arc Remelted Pitting Resistance (PREN ≥ 26) ASTM F138 Grade 2

ASTM F543 Biomechanical Quality Verification

Every production batch manufactured at ZATH is subjected to randomized mechanical destruction and non-destructive optical profilometry testing under standardized laboratory parameters:

1. Torsional Yield Torque & Breaking Angle Evaluates insertion failure limits. Torx (hexalobular) recess drives allow 38% higher torque transmission than hexagonal sockets before cam-out or socket stripping occur.

2. Axial Pullout Force Testing Conducted in calibrated polyurethane foam blocks (ASTM F1839). Deep thread profiles and fine pitch ensure high grip strength in cellular synthetic bone structures.

3. Driving Torque & Self-Tapping Insertion Measures the cutting force required to traverse cortical walls. Three-flute asymmetric cutting geometry reduces thermal necrosis during initial orthopedic placement.

Direct-from-Factory B2B Architecture

Orthopedic Screw Pricelist & Tiered Sourcing Guide

Transparency in OEM/ODM contract pricing enables international distributors and hospital groups to forecast landed margins precisely. The following matrix outlines industry-standard volume tiers (EXW/FOB Beijing) for certified sterile and non-sterile configurations.

Classification & Diameter	Material Grade	Drive / Design Features	Tier 1 (500–2,000 pcs)	Tier 2 (2,001–10,000 pcs)	Tier 3 (OEM Enterprise 10k+)	Packaging / Lead Time
Cortex Screw (Ø2.0mm – Ø2.7mm) Mini Fragment System	Ti-6Al-4V ELI / 316LVM	Hex / T8 Torx, Self-Tapping, Spherical Head	$4.80 – $6.50	$3.60 – $4.90	$2.40 – $3.20	Sterile Blister / 7–14 Days
Locking Screw (Ø3.5mm – Ø5.0mm) Trauma LCP Compatibility	Ti-6Al-4V ELI (ASTM F136)	Threaded Conical Head, Star T15/T25 Recess	$6.20 – $8.40	$4.70 – $6.10	$3.10 – $4.20	Sterile Peel-Pack / 10–20 Days
Cannulated Compression (Ø4.0mm – Ø7.3mm) Femoral Neck & Subcapital	Ti-6Al-4V ELI / Stainless	Central Guide-Wire Lumen, Partial/Full Thread	$11.50 – $16.00	$8.80 – $12.50	$6.20 – $8.90	Double-Barrier Sterile / 14 Days
Headless Compression (Herbert Type) Scaphoid & Small Joint Arthrodesis	Ti-6Al-4V ELI	Differential Variable Pitch, Zero-Prominence	$14.00 – $19.50	$10.50 – $14.80	$7.50 – $10.20	Sterile Single-Pack / 15 Days
Spinal Pedicle Screw (Ø5.5mm – Ø6.5mm) Polyaxial / Monoaxial / MIS	Ti-6Al-4V ELI + CoCr Lock Ring	Friction-fit head, 50° Angulation, Dual Thread	$26.00 – $36.00	$19.50 – $27.00	$14.00 – $18.50	Class 10k Sterile / 20 Days

Raw Bar Stock Indexing

Raw medical-grade titanium pricing fluctuates with international titanium sponge indices. ZATH maintains long-term billet reserves to shield overseas partners from localized commodity shocks.

Custom Thread & OEM Tooling

Tooling setup fees are waived for contract volumes surpassing 5,000 units per geometry. Complete private label laser etching (UDI compliant) and custom tray arrangement are available.

Sterilization & Packaging Cost

Pre-sterilization packaging (EtO gas or Gamma irradiation) in medical-grade Tyvek blisters adds approximately $0.60–$1.20 per unit, delivering substantial savings compared to in-hospital reprocessing.

Smart Manufacturing Ecosystem

China Factory 4.0: Precision CNC & Integrated Resilience

Established in 2009 within the Zhongguancun Science Park (Pinggu, Beijing), Beijing ZhongAnTaiHua Technology Co., Ltd. (ZATH) exemplifies advanced medical hardware engineering, operating modern multi-axis Swiss turn-mill centers and cleanroom automation.

Swiss High-Speed Machining

Multi-axis Citizen and Star Swiss-type lathes execute simultaneous thread-whirling, socket broaching, and cutting flute milling in a single setup, guaranteeing axial run-out below 0.005mm.

Automated Optical CMM

High-resolution non-contact vision inspection machines capture thread pitch, crest-to-root radii, and flank angles against CAD masters, automatically rejecting out-of-tolerance units.

Surface Anodizing

Type II electrochemical anodization establishes hard, bio-inert wear coatings while color-coding diameters (e.g., gold 3.5mm, blue 2.7mm, green 5.0mm) for instantaneous surgical recognition in the OR.

Class 10k Cleanrooms

Final ultrasonic degreasing, pyrogen-free multi-stage water rinsing, and double-sterile Tyvek heat sealing operate strictly within certified Class 10,000 / Class 100,000 cleanroom zones.

15+

Years Industry Heritage (Est. 2009)

300+

Dedicated Production Personnel

100≈

Senior QA & Biomedical Engineers

4-6d

Express Global Dispatch Timelines

Clinical Application Scenarios

Anatomical Matching & Operative Precision

From metaphyseal buttressing to spinal column stabilization, bone screws must perform reliably across varied bone mineral densities and biological stresses.

Periarticular Trauma & LCP Fixation

In distal radius, proximal humerus, and tibial plateau reconstruction, locking screws thread securely into anatomical plates. This converts the plate-screw assembly into an internal fixator, safeguarding the periosteal blood supply and preventing collapse under secondary postoperative loading.

Spinal Deformity & MIS Pedicle Stabilization

Integrated into systems such as the ZATH Zipper 6.0 Spinal Platform, polyaxial and cannulated pedicle screws feature dual-lead cortical-cancellous threads that optimize purchase along the pedicle isthmus while seating firmly in vertebral bodies.

Extremities & Sports Medicine Repair

Headless cannulated compression screws (Herbert configuration) enable percutaneous scaphoid fixation and hallux valgus osteotomies. Subchondral countersinking ensures smooth gliding beneath surrounding articulating cartilage.

Authoritative Compliance

Certified for Global Market Entry: ISO 13485 & UDEM Audit Integrity

International health authorities require verified quality management systems and comprehensive device dossiers. ZATH supports procurement and regulatory teams with accessible certifications, technical construction files, and material traceability.

ISO 13485:2016

Fully audited QMS encompassing design, CNC machining, cleanroom packaging, and lot-level traceability.

UDEM Notified Body

Conformity certification confirming compliance with European safety, design, and performance directives.

Free Sale Certificates

Governmentally notarized FSC documentation expediting regional Ministry of Health registrations worldwide.

100% Heat Traceability

Every shipment includes mill test certificates (MTC), chemical assays, and mechanical tensile logs.

Technical & Sourcing FAQ

Direct Questions from Procurement Directors

Clear answers to high-friction questions regarding regulatory transfer, private labeling, order quantities, and surgical instrumentation compatibility.

What are the exact Minimum Order Quantities (MOQ) for custom OEM orthopedic screws?

For standard catalog designs (cortex, cancellous, and universal locking screws in standard lengths), the trial MOQ is 100 units per specification. For custom thread pitches, proprietary drive configurations, or customer-branded laser labeling, the standard production run starts at 500 units per SKU. Blank prototyping runs can be arranged for mechanical pullout and validation testing prior to full production commitments.

How does ZATH guarantee compatibility with existing third-party locking plates?

Locking screws utilize standardized conical head thread profiles (including 20° spherical radius tapers) compatible with major international locking compression plate (LCP) systems. Custom taper angles, variable-angle (VA) locking rings, and matching self-centering drill guides can be reverse-engineered or manufactured to your CAD master prints to ensure smooth cross-threading prevention.

What documentation is provided to support regional Ministry of Health registrations?

Qualified distributors receive comprehensive technical documentation, including ISO 13485 certificates, Declarations of Conformity, Free Sale Certificates (FSC), raw material chemical/mechanical mill test sheets, biocompatibility evaluations (ISO 10993 series), and ASTM F543 biomechanical test summaries. We routinely assist partners with local dossier submissions across Southeast Asia, Latin America, the Middle East, and Eastern Europe.

What is the shelf life and sterilization validation methodology for sterile-packed screws?

Sterile configurations are packed in medical-grade Tyvek blister trays within validated Class 10,000 cleanrooms and processed using validated Ethylene Oxide (EtO) or Gamma irradiation cycles, achieving a Sterility Assurance Level (SAL) of $10^{-6}$. Packaging integrity is backed by real-time and accelerated aging studies confirming a 5-year barrier shelf life under ISO 11607-1/2 guidelines.

Can matching surgical instrumentation sets (screwdrivers, depth gauges, drill bits) be included?

Yes. ZATH engineers and manufactures matching surgical instrument sets for each fixation system. Screwdriver shafts are machined from hardened medical-grade stainless steel (such as 17-4PH or custom tool steels) with titanium nitride (TiN) or diamond-like carbon (DLC) coatings to prevent tip wear and ensure secure screw retention. Trays are built from anodized aluminum or PPSU for repeat autoclave durability.

What lead times can distributors expect for standard vs custom OEM orders?

Standard inventory sizes ship within 3 to 7 business days from our Beijing facility. For OEM volume orders with custom laser etching and sterile packaging, lead times typically range from 2 to 4 weeks depending on batch volume. Urgent replenishments are dispatched via global air couriers (DHL, FedEx, UPS) with transit windows of 4 to 6 days.

Precision Portfolio Showcase II

Advanced Trauma Plates & Reconstruction Assemblies

Engineered for anatomical alignment, low profile soft-tissue clearance, and dependable screw locking purchase across complex trauma and reconstructive cases.

Hand / Foot Cheap Metacarpal & Metatarsal Fractures 1/3 Tubular Locking Plate