OIC Legal & Business Policy

Terms & Conditions

Notice to International Buyers, OEM Partners & Healthcare Authorities: The Orthopaedic Implant Company ("OIC") manufactures clinically proven, FDA-cleared, and ISO 13485:2016 certified orthopaedic trauma implants. These Terms and Conditions govern all commercial transactions, bulk procurement contracts, international distribution agreements, and digital platform usage. By requesting quotations, issuing purchase orders, or executing contracts, you agree to these governing terms.

1. Website Use & Intellectual Property Rights

All materials published on this platform—including technical specifications, surgical technique manuals, CAD implant profiles, metallurgical data, logo marks, and proprietary system names (e.g., Flex-Fix™, Metacarpal Nail Systems)—are protected under United States and international intellectual property laws.

  • Authorized Usage: Medical professionals, hospital procurement managers, and authorized international distributors may download product documentation strictly for clinical evaluation, hospital bidding, or purchasing purposes.
  • Restrictions: Unauthorized replication, reverse-engineering of implant geometry, re-labeling, or commercial redistribution without express written consent from OIC management is strictly prohibited.

2. ISO 13485 Manufacturing Standards & E-E-A-T Assurance

OIC operates under strict U.S. FDA Quality System Regulations (QSR / 21 CFR Part 820) and ISO 13485:2016 Medical Device Quality Management System certifications. Every orthopaedic implant—ranging from intramedullary titanium nails to locking bone plates and cannulated screws—undergoes rigid quality control and material verification.

Biocompatible Materials

Manufactured exclusively using medical-grade Titanium Alloys (ASTM F136 / ISO 5832-3) and Implant-Grade Stainless Steel (ASTM F138 / ISO 5832-1) with complete heat-lot traceability.

Clinical Verification

Designed and vetted in collaboration with practicing orthopaedic trauma surgeons to deliver equivalent or superior mechanical performance compared to legacy premium-tier vendors.

3. B2B Sales, Pricing & Order Acceptance

OIC provides value-based pricing engineered to reduce medical device procurement costs by 50% to 60% compared to traditional market averages.

Purchase Orders & Contract Terms

  • Quotation Validity: Official B2B price quotations remain valid for 30 calendar days unless specified otherwise in written international distribution agreements.
  • Order Binding: Orders become contractually binding only upon written confirmation from OIC or upon dispatch of the ordered medical inventory.
  • Payment Terms: Wire transfers (T/T), Letter of Credit (L/C at sight), and Net 30/60 terms are available for accredited hospital networks and authorized regional distributors subject to credit review.

4. International Shipping, Incoterms & Customs Export

OIC facilitates efficient global supply chain logistics to deliver surgical implants and instrument sets safely to operating rooms and distribution hubs across Asia, Europe, Latin America, and the Middle East.

Standard delivery terms are executed under FOB Origin (Reno, Nevada, USA) or CIF / DDP as agreed upon in specific commercial purchase contracts. Risk of loss passes to the purchaser upon carrier handover, while OIC provides robust sterile-barrier packaging compliance to preserve product integrity during transit.

5. Warranty, Defect Claims & Return Policy

OIC warrants that all implants and surgical instruments are free from structural material defects and conform strictly to manufacturing drawings and regulatory filings.

  • Inspection Window: Buyers must inspect incoming shipments within ten (10) business days of receipt and notify OIC in writing of any shipping discrepancies or packaging breaches.
  • Sterile Barrier Integrity: Implants with compromised sterile packaging must be quarantined immediately and reported with batch lot details for rapid replacement under warranty.
  • Single-Use Implants: Orthopaedic implants are strictly non-reusable single-use devices. Any re-sterilization or re-implantation voids all structural warranties and liabilities.

6. Global Regulatory Compliance & Vigilance

Purchasers and international distributors agree to maintain complete lot-tracking and serial traceability records for a minimum of seven (7) years in accordance with international medical device vigilance regulations (such as US FDA UDI tracking and EU MDR requirements).

Distributors must immediately report any adverse medical event or customer complaint involving OIC implants to OIC’s Regulatory Affairs Department within 24 hours of notification.

7. Limitation of Liability & Governing Law

To the maximum extent permitted by law, OIC’s aggregate liability for any commercial claim, breach of contract, or product defect shall not exceed the net purchase price paid by the customer for the specific batch of goods giving rise to the claim. All contracts shall be governed by the laws of the State of Nevada, USA, with international arbitration conducted under American Arbitration Association (AAA) rules.

Looking for Value-Based Implant Solutions?

Connect with our international sales team to request price catalogs, FDA/CE compliance certificates, or hospital procurement proposals.

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