ISO 13485 Certified Surgical Equipment

Orthopedic Instrument Sets

Surgical-Grade Orthopedic Tool Sets & Custom Instrument Trays

Shanghai CareFix Medical Instrument Co., Ltd. designs and manufactures high-precision orthopedic surgical instrument kits engineered for trauma surgery, limb reconstruction, pediatric orthopedics, and joint stabilization. Each kit is ergonomically styled and manufactured to exacting tolerances to maximize intraoperative efficiency and reduce surgical time.

Fabricated from premium medical-grade German stainless steel (17-4PH / 316L) and lightweight anodized titanium/aluminum alloys, CareFix surgical kits endure rigorous sterilizing routines while maintaining micron-level alignment and tactile precision.

Medical Steel Grade German 17-4PH & 316L Stainless
Sterilization Standards Autoclavable 134°C (ISO 17665)
Coupling & Drivers AO-Standard Quick-Coupling System
Quality Assurance ISO 13485 & CE Compliant

Manufacturer Competence

State-Level Cleanroom Facility

Self-owned manufacturing complex in Shanghai Songjiang National Economic Zone.

16+ Years Clinical Innovation

Developed in close cooperation with top-tier orthopedic surgeons and hospitals worldwide.

Global Hospital Trust

Equipping 365+ major medical centers across 32+ international territories.

Featured Orthopedic Surgical Instrument Kits

Comprehensive specialized instrument sets engineered for specific clinical applications, matching CareFix external fixators, locking plates, intramedullary nails, and pediatric systems.

Unilateral Metallic Fixator Instrument Kit for Limb Reconstruction Ext Fixation

Unilateral Metallic Fixator (Limb Reconstruction) Instrument Kit

Complete set of drill guides, pin insertion wrenches, bone pin drivers, and rod tensioners tailored for complex limb lengthening and bone transport procedures.

Application:Limb Reconstruction / Deformity
Tray Material:Anodized Aluminum Caddy
Standard:ISO 13485 / CE Compliant
Unilateral External Fixator Wrist Instrument Kit Wrist & Trauma

Unilateral External Fixator (Wrist) Instrument Kit

Precision micro-drill guides, distraction handles, and tightening tools formulated for distal radius fractures and wrist joint external fixation.

Application:Wrist Joint / Distal Radius Fixation
Pin Sizes:Ø2.5mm - Ø3.5mm Pin Instruments
Standard:ISO 13485 Certified
Telescopic Intramedullary Nail Instrument Kit Ø3.6-6.5 Pediatric Nailing

Telescopic Intramedullary Nail Instrument Kit Ø3.6-6.5

Specialized reamers, insertion guides, driving caps, and locking key instruments dedicated to telescopic intramedullary nailing in Osteogenesis Imperfecta (OI).

Nail Compatibility:Ø3.6mm - Ø6.5mm Telescopic Nails
Features:Targeting Jig & Depth Gauges
Standard:ISO 13485 / Autoclavable
Extraosseous Talotarsal Stabilization Instrument Kit Foot & Ankle

Extraosseous Talotarsal Stabilization Instrument Kit

Surgical sizers, trial implants, cannulated drivers, and sinus tarsi probes designed for pediatric and adult flatfoot correction procedures.

Indication:Subtalar Joint Arthroereisis
Driver Type:AO Quick-Coupling Cannulated
Standard:ISO 13485 Certified
2.0/2.5 Double Compression Cannulated Screw Instrument Kit Cannulated Screws

2.0/2.5 Double Compression Cannulated Screw Instrument Kit

Fine Kirschner wire guides, countersinks, cannulated drills, and torque-limiting screwdrivers for headless compression screw fixation in hand and foot surgery.

Screw Range:Ø2.0mm & Ø2.5mm Headless Screws
Precision:Micro-cannulated drills included
Standard:CE / ISO 13485
Growth Plate Instrument Kit for Guided Growth 8-Plate Pediatric Ortho

Growth Plate Instrument Kit (Guided Growth 8-Plate)

Plate benders, drill sleeves, and screw drivers optimized for hemiepiphysiodesis procedures to correct angular limb deformities in growing children.

Indication:Genu Valgum / Varum Correction
Kit Components:Contouring pliers, drills, gauges
Standard:ISO 13485 Certified
2.7/3.5 LCP Instrument Kit Locking Plates

2.7/3.5 LCP Instrument Kit

Threaded drill sleeves, depth gauges, torque-limiting screwdrivers, and plate bending irons for 2.7mm and 3.5mm small fragment locking compression plates.

System Size:Small Fragment 2.7mm / 3.5mm LCP
Tray Design:Dual-layer sterilization box
Standard:ISO 13485 / CE Compliant
2.7/3.5 LCP PFP Instrument Kit Proximal Femur

2.7/3.5 LCP Proximal Femoral Plate (PFP) Instrument Kit

Dedicated anatomical targeting guide jibs, cannulated drill sleeves, and screw insertion shafts for pediatric proximal femoral osteotomy locking plates.

Indication:Pediatric DDH & Femoral Osteotomy
Feature:Anatomical Targeting Guides
Standard:ISO 13485 Certified
5.0 LCP PFP Instrument Kit Heavy Fragment

5.0 LCP Proximal Femoral Plate (PFP) Instrument Kit

Heavy-duty drill bits, large-fragment torque wrenches, targeting frames, and robust plate benders designed for adolescent and adult proximal femur fixation.

System Size:5.0mm Large Fragment LCP PFP
Material:High-Yield Strength Stainless Steel
Standard:ISO 13485 / CE Compliant
Fore-middle Foot Basic Operation Instrument Kit Forefoot Surgery

Fore-middle Foot Basic Operation Instrument Kit

Essential osteotomes, bone levers, micro-retractors, tissue forcep sets, and wire benders for hallux valgus, midfoot arthrodesis, and metatarsal osteotomies.

Indication:Forefoot & Midfoot Reconstruction
Finish:Satin Anti-Glare Surface
Standard:ISO 13485 Certified
Micro Locking Plate Instrument Kit Ø1.5/2.0/2.4/2.7 Hand & Maxillofacial

Micro Locking Plate Instrument Kit Ø1.5/2.0/2.4/2.7

Ultra-precise micro-drill guides, delicate plate benders, fine screwdriver shafts, and color-coded screw rack trays for mini/micro fragment hand and foot surgery.

Screw Diameters:Ø1.5mm / 2.0mm / 2.4mm / 2.7mm
Tray Format:Color-coded modular compartments
Standard:ISO 13485 / CE Certified

Built for Operating Room Reliability

CareFix surgical tools are manufactured with uncompromising metallurgical strictness, ensuring long operational lifespan and unyielding surgical reliability.

German Stainless Steel

Forged from high-tensile 17-4PH and 316L surgical steel, delivering high fatigue strength and resistance to stress corrosion cracking.

AO Quick-Coupling Standard

Universal quick-connect fittings across screwdrivers, reamers, and drill shafts allow seamless integration with global power tools.

Sterilization Box Engineering

Aircraft-grade anodized aluminum caddies equipped with high-temperature silicone brackets designed to endure 1,000+ steam autoclave cycles.

Micron CNC Machining

5-Axis Swiss CNC turning and milling ensures sub-micron dimensional accuracy on targeting jigs, drill bits, and driver tip profiles.

CareFix Instrument Manufacturing Specifications

Key engineering specifications for international hospital tenders and distributor procurement teams.

Parameter / Feature CareFix Specification Standard Clinical Advantage
Raw Material 17-4PH / 316L Medical Stainless Steel, Titanium Gr5 Prevents instrument flexing and tip rounding under heavy torque load
Surface Finish Passivated & Electro-polished Matte Anti-Glare Finish Reduces optical glare under intense operating theatre lamps
Sterilization Compatibility 134°C (273°F) Autoclave / EO Gas / Gamma Ray Fully compliant with hospital CSSD reprocessing protocols
Driver Coupling Interface AO Quick Coupling / Hexagonal / Star Torque Fast intraoperative tool exchanges with power drivers & hand pieces
Marking & Identification High-contrast Laser Etched Size & Part Numbers Quick tool recognition by scrub nurses and CSSD inventory staff
Quality Certification ISO 13485:2016 Medical Device QMS Certification Ensures regulatory compliance for hospital tender submission

Frequently Asked Questions for Distributors & Procurement

Technical and logistical insights for medical device buyers, hospital agents, and surgical teams.

What is the average lead time for wholesale instrument set orders?

Standard catalog instrument sets are maintained in safety stock and can be dispatched within 7–10 business days. Custom or OEM tray configurations typically require 3–4 weeks depending on batch quantities and tray modification requests.

Can CareFix supply replacement individual instruments for existing sets?

Yes. Every instrument item in our catalog carries a unique laser-etched SKU number, allowing hospitals and agents to order single replacement drills, taps, screwdrivers, or drill sleeves without re-purchasing complete kits.

Do you offer customized laser marking and OEM tray layout services?

CareFix provides comprehensive OEM/ODM services including distributor brand laser etching, color-coded anodizing for aluminum trays, and custom silicone bracket layouts tailored to your hospital system requirements.

What documentation is provided for hospital regulatory approval?

Each delivery includes ISO 13485 quality certificates, material batch test reports, passivation test results, sterilization protocol instructions (IFU), and Declaration of Conformity documents for global customs clearance.

Request Technical Specifications & Wholesale Pricing

Connect directly with CareFix orthopedic engineering specialists for customized product quotes, OEM tray customization, or global distributor partnership terms.

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