What certifications do Orthi Medical products have?

Our quality system operates under ISO 13485 and ISO 9001, and applicable products carry CE marking. Implant raw materials follow ASTM F67 (pure titanium TA2/TA3) and ASTM F1472 (Ti-6Al-4V / TC4) specifications.

Do you offer OEM and private label orthopedic products?

Yes. We provide OEM/ODM services including drawing-based machining of implants and instruments, laser marking, anodized color coding, custom instrument trays, private label packaging and regulatory documentation support.

Can implants be supplied sterile?

Bone screws, bone plates, intramedullary nails and cannulated screws can be supplied in sterile packages sterilized by Co-60 gamma irradiation with a sterility assurance level of SAL 10-6.

Which product lines are available for distributors?

Trauma plates, screws and nails; spinal pedicle screws, cages and cervical plates; sports medicine anchors and arthroscopy instruments; hip and knee arthroplasty systems; UBE and endoscopic imaging systems; coronary and ureteral stents; and sterile packaged implants.

Do you provide surgeon training and technical support?

Yes. We support distributors with surgical technique guides, product training, academic conferences, cadaver workshops and case-based technical support.

Custom OEM Headless Compression Screw Factory & Supplier

Precision-Engineered Orthopedic Fasteners, Differential Pitch Thread Technology & ISO 13485 Certified Medical Device Manufacturing Solutions

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±0.003 mm

Micro-Machining Precision

ISO 13485

Quality Management System

SAL 10⁻⁶

Gamma Sterilization Assurance

100%

Batch Traceability & QC

Engineering Fundamentals of Custom Headless Compression Screws

In modern orthopedic trauma and sports medicine surgery, maintaining rigid interfragmentary compression without implant prominence is paramount. The Headless Compression Screw (HCS)—frequently manufactured with dual variable-pitch threads or continuous differential threading—is specifically designed to solve the anatomical challenges posed by intra-articular fractures, scaphoid non-unions, osteochondral fractures, and distal radius reconstructions.

Unlike standard bone screws that rely on a protruding screw head to exert compressive force against the outer cortex, a headless compression screw buries completely below the articular cartilage or periosteal surface. This flush or sub-cartilaginous profile prevents soft-tissue impingement, tendon irritation, and joint stiffness, permitting early post-operative patient mobility and superior long-term clinical outcomes.

Differential Pitch Mechanics

The leading (distal) thread advances faster into the distal fragment than the trailing (proximal) thread advances into the proximal fragment. As the screw is driven, the disparity in lead pitch automatically draws the two bone fragments together, generating high-velocity dynamic axial compression.

Cannulated Core Alignment

Manufactured with ultra-precise concentric cannulation through 5-axis Swiss CNC gun-drilling. The central lumen allows accurate intraoperative placement over a temporary Kirschner wire (K-wire), ensuring minimal tissue trauma during minimally invasive percutaneous procedures.

Star-Drive / Hexalobular Recess

Equipped with precision-machined internal hexalobular drive sockets (Torx-compatible) that maximize torque transmission, eliminate driver cam-out, and prevent driver head stripping even under extreme insertion forces in dense cortical bone.

Micro-Screw Specification & Engineering Dimensions Matrix

As a specialized OEM/ODM medical device contract manufacturer, our factory produces headless compression screws in a wide spectrum of diameters and lengths tailored to specific anatomical fixations:

Screw Category	Outer Dia. (Distal/Proximal)	Cannulation ID	Length Range	Primary Indications	Raw Material Standard
Micro Headless Compression Screw	Ø 1.5 mm / Ø 2.0 mm	Ø 0.7 mm (0.028" K-Wire)	8 mm – 30 mm	Phalangeal, metacarpal & osteochondral fractures	Ti-6Al-4V ELI (ASTM F136 / F1472)
Mini Headless Compression Screw	Ø 2.2 mm / Ø 3.0 mm	Ø 0.9 mm (0.035" K-Wire)	10 mm – 40 mm	Scaphoid, carpal bones, radial head fractures	Ti-6Al-4V ELI / 316LVM (ASTM F138)
Standard Headless Screw	Ø 3.5 mm / Ø 4.0 mm	Ø 1.2 mm (0.045" K-Wire)	14 mm – 60 mm	Distal radius, medial malleolus, osteotomies	Titanium Alloy / Stainless Steel
Large Cannulated Headless Screw	Ø 4.5 mm / Ø 7.0 mm	Ø 1.6 mm – Ø 2.2 mm	20 mm – 110 mm	Tarsal/Metatarsal fusion, calcaneus, subtalar arthrodesis	Medical Grade Titanium (Type II Anodized)

Our Factory's OEM/ODM Customization Capabilities

Orthi Medical Co., Ltd. operates state-of-the-art CNC machining infrastructure, Class 100,000 cleanrooms, and automated passivating/anodizing lines dedicated to fulfilling contract manufacturing contracts for international orthopedic device brands.

Multi-Axis Swiss CNC Precision

Utilizing 7-axis Citizen and Star Swiss-type automatic lathes, we achieve concentricity tolerances down to ±0.003 mm and surface roughness values of Ra < 0.4 µm. This guarantees flawless thread geometry and smooth K-wire sliding during surgical deployment.

ASTM Compliant Implant Alloys

We work exclusively with certified medical-grade raw materials: Titanium Grade 5 / Ti-6Al-4V ELI (ASTM F136 / ASTM F1472), High-Nitrogen Stainless Steel (ASTM F138 316LVM), and PEEK. Complete material heat-number certificates and chemical composition documentation are provided with every delivery batch.

Type II Anodization & Color Coding

Custom electro-chemical surface passivation and Type II titanium anodization improve fatigue strength and bio-inertness while offering vibrant intraoperative color coding (gold, blue, magenta, green) for fast dimension identification by surgical staff.

End-to-End OEM Contract Manufacturing Workflow

From custom CAD blueprint validation to cleanroom packaging, our disciplined engineering pipeline guarantees predictable delivery cycles and strict regulatory conformity.

Design & DFM Review

Engineering evaluation of thread pitch ratios, drive socket tolerances, and material stress limits.

Rapid Prototyping

Precision CNC sample turnarounds within 7-10 days, accompanied by full optical measurement reports.

Automated Production

Multi-spindle Swiss turning with inline laser gauging and continuous thread profile monitoring.

Sterile Packaging & QC

ISO Class 7 cleanroom double-blister packaging, Co-60 gamma sterilization, and CE file assembly.

Future Trends in Headless Compression Screw Technology & Sourcing

As minimally invasive surgical (MIS) techniques advance and ambulatory surgery centers (ASCs) expand globally, the market demand for headless compression screws is undergoing transformative technological shifts. Medical device procurement teams must align with suppliers capable of supporting next-generation implant innovations.

1. Continuous Variable-Pitch Threading Architecture

Traditional dual-threaded screws possess a smooth central shank separating distal and proximal threads. However, next-generation continuous variable-pitch headless screws feature a thread profile whose pitch progressively tightens along the entire length of the screw shaft. This design distributes axial compression forces seamlessly across the fracture line, eliminates stress concentration zones, and provides superior resistance to screw pull-out in osteopenic bone.

2. Smart Sterile Single-Use Kit Systems

Hospital purchasing departments are actively shifting away from bulk non-sterile implant trays requiring expensive and energy-intensive hospital autoclave processing. The future of medical procurement lies in pre-packaged, single-use procedure kits containing a sterile headless compression screw alongside disposable guide wires, countersinks, drills, and driver bits. This model guarantees sterility, reduces operating room turnaround times, and simplifies hospital billing.

3. Porous Additive Surface Treatments & Bio-Absorbable Formulations

Advancements in surface engineering involve applying porous titanium micro-coatings (via chemical etching or selective laser sintering) to the central non-threaded section of the screw, accelerating direct bone osseointegration. Furthermore, contract research into bio-absorbable magnesium alloy matrices is paving the way for headless screws that gradually degrade into natural bone mineral over 18 to 24 months, eliminating the need for hardware removal surgeries.

Frequently Asked Questions (FAQ) for OEM Sourcing Managers

Here are expert answers to the most common engineering, quality, and supply chain queries encountered when procuring custom OEM headless compression screws.

Q1 How does a headless compression screw generate interfragmentary compression without a traditional screw head?

Compression is achieved mechanically through differential thread pitch. The leading (distal) thread has a larger pitch (advances further per revolution) than the trailing (proximal) thread. As the screw crosses the fracture line into the far fragment, the trailing thread enters the near fragment at a slower rate. This differential rate of linear travel pulls the distal bone fragment toward the proximal fragment, generating controlled, dynamic axial compression without needing a protruding screw head.

Q2 What are the key manufacturing tolerances required for high-performance cannulated headless screws?

Critical dimensions include cannulation inner diameter concentricity (typically held within ±0.005 mm relative to the outer thread diameter), pitch lead tolerance within ±0.002 mm, and drive socket depth uniformity. Maintaining strict concentricity prevents drill bit binding or guide wire jamming during delicate percutaneous surgical procedures.

Q3 Why is Ti-6Al-4V ELI (ASTM F136) preferred over stainless steel for small joint headless screws?

Ti-6Al-4V ELI (Extra Low Interstitial) titanium alloy provides a modulus of elasticity closer to human cortical bone than stainless steel, reducing stress shielding. Furthermore, titanium exhibits superior biocompatibility, generates significantly fewer artifacts under MRI and CT imaging, and possesses higher fatigue strength per unit weight, making it ideal for micro-fixation in hand, wrist, and foot surgery.

Q4 Can your factory supply sterile pre-packaged screws certified for international market distribution?

Yes. We offer turnkey sterile packaging solutions conducted in ISO Class 7 cleanrooms. Implants are sealed in medical-grade Tyvek blister packs and subjected to Cobalt-60 Gamma Irradiation, achieving a Sterility Assurance Level (SAL) of 10⁻⁶. Every sterile box is labeled with UDI barcodes, lot numbers, and expiration dating ready for immediate hospital deployment.

Q5 What mechanical testing documentation is provided to support regulatory approval (CE Marking / FDA 510k)?

We perform full mechanical testing according to ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws), including Torsional Yield Strength, Maximum Torque to Failure, Drive Torque, Axial Pull-out Strength, and Dynamic Axial Compression performance. Detailed test protocol reports and material traceability dossiers are furnished to support your regulatory submissions.

Q6 Do you manufacture matching custom surgical instruments and driver shafts for OEM screw sets?

Absolutely. A complete implant system requires dedicated instrumentation. We manufacture custom cannulated drill bits, countersinks, depth gauges, K-wire guide sleeves, and quick-coupling hexalobular driver shafts. All instruments are built from biocompatible surgical stainless steels (17-4PH, 420, 316L) designed for repeated sterilization cycles.

Q7 What is the minimum order quantity (MOQ) and lead time for custom OEM prototyping?

For custom design prototypes, our typical lead time is 7 to 14 working days following final CAD blueprint sign-off. We accommodate small validation batch sizes starting from 50 to 100 units per size for clinical trials and mechanical testing, ramping up seamlessly to mass production orders of tens of thousands of units per month.

Accelerate Your Orthopedic OEM Supply Chain

Partner with an ISO 13485 certified contract manufacturer capable of turning your engineered concepts into market-ready, sterile-packaged headless compression screws. Send your technical drawings or product specs to our engineering team today.