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NMPA Review Report Released for Israeli Osteosynthesis Plate System

The NMPA granted innovation approvals to Israeli company CarboFix Orthopedics’ carbon fiber polyetheretherketone (PEEK) osteosynthesis plate system and issued a review report.

These published review reports serve as important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review the relevant ones for our clients’ specific products to gain more clarity and be more efficient in their submission and approval process. As NMPA standardizes and streamlines the review process for fast-track approval, big players in the space like Synthes, TORNIER, Wright Medical, LimaCorporate, Evonos, LSM Med, Spineway, and Bioplate can benefit from our expertise and experience.

Product Description, Pre-clinical and Clinical

Product overview

  • Product structure and composition

This product consists of osteosynthesis plates and bone screws. The osteosynthesis plate is made of carbon fiber PEEK composite material with the material grade PEEK-OPTIMA LT3PPT50A, and the PEEK material used in this product complies with the specifications of standard YY/T 0660. The osteosynthesis plate has opaque positioning markers made of tantalum material in accordance with the standard YY/T 0966. The bone screws are made of TC4ELI titanium alloy material in accordance with the standard GB/T 13810, and their surfaces undergo colored anodized treatment. The osteosynthesis plates are sterilized and packaged in sterile packaging using steam sterilization with a sterilization validity period of 5 years. The bone screws are packaged non-sterile.

  • Intended Use

This product is intended for internal fixation of limb fractures.

  • Model/Specification
  • Working principle

This product is used in open surgical procedures. It involves placing the osteosynthesis plate to achieve fracture reduction and inserting bone screws for compression and fixation.

Pre-clinical

  • Product Technical Requirements (PTRs) research

Email us at info@ChinaMedDevice.com for the research items table

  • Product Performance Evaluation

Product material and chemical characterization data include those for physicochemical performance quality control for the carbon fiber PEEK composite material made from pre-impregnated tapes, tantalum metal, and titanium alloy materials, and validation for the osteosynthesis plate compression molding process, the uniform distribution of carbon fibers, and verification for the titanium alloy colored anodization process.

Physical and mechanical performance data include those for hardness of the osteosynthesis plate, static and dynamic bending performance, twisting performance, axial pull-out force, insertion and removal torque of bone screws, self-tapping performance, maximum torque, pull-out force, and wear performance when bone screws are used in conjunction with the osteosynthesis plate, and wear performance after fatigue of the osteosynthesis plate system.

Provide research data on magnetic resonance compatibility, tantalum wire visibility, and the impact of carbon fiber arrangement on the mechanical performance of the product.

  • Biocompatibility

Evaluation data include extraction, leachables, and toxicology studies of the carbon fiber PEEK composite material.

Test data encompass cytotoxicity, delayed-type hypersensitivity, intradermal reactivity, acute systemic toxicity, subacute systemic toxicity, genetic toxicity, and implantation tests.

Also, evaluation data for titanium alloy and tantalum metal materials are provided. Safety study data for carbon fiber polyetheretherketone wear debris are presented. Verification data for the osteosynthesis plate compression molding process, confirming the absence of additives, release agents, or other processing aids, are included. The thermal test report for a carbon fiber polyetheretherketone pedicle screw system with the same materials and production processes as the declared product is provided. Additionally, the cytotoxicity test report for a titanium alloy intramedullary nail system with the same materials and production processes as the declared product is supplied.

  • Sterilization
  • Product Shelf Life and Packaging
  • Others

The bone screws are products in the “Catalog of Medical Devices Exempted from Clinical Evaluation”. The applicant provided comparative information between the applied products and the terms in the “Catalog”, as well as comparative information with similar products already on the market.

Clinical Evaluation

The applicant chose predicate comparison to conduct to conduct clinical evaluation. It selected osteosynthesis plate products from established manufacturers such as Synthes GmbH, TORNIER S.A.S., Wright Medical, which are already on the China market. The applicant compares the declared product with these similar products in terms of scope of application and structural composition, with the main difference lying in the material composition of the osteosynthesis plate. For the differing aspects, the applicant provides comparative data on the mechanical performance and wear debris research between the declared product and similar products. Additionally, sales data from overseas markets for the product from 2013 to 2023 is presented. Adverse events and complications occurring after the overseas market launch are summarized and analyzed for correlation with the product. This analysis aims to demonstrate the equivalence of the declared product to similar products already on the market and prove that the differences do not affect the safety and effectiveness.

Risk-Benefit Analysis

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