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510(k) Data Aggregation

    K Number
    K192447
    Device Name
    Superelastic Staple
    Manufacturer
    Neosteo
    Date Cleared
    2020-02-28

    (175 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K070031,K142111,K061798
    Why did this record match?
    Device Name :

    Superelastic Staple

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Superelastic Staple are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

    Device Description

    The Superelastic Staple consists of staples available in several lengths. All the implants are made of NiTi alloy.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called the "Superelastic Staple." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that no clinical studies were performed.

    Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no clinical performance data for the device's efficacy or accuracy is presented in the provided document.

    The document details the following regarding the device and its assessment:

    • Device Name: Superelastic Staple
    • Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
    • Regulatory Class: Class II
    • Product Code: JDR
    • Indications for Use: The Superelastic Staple is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
    • Predicate Devices:
      • Biopro Memory Staples® (K061798) from Biopro (Primary)
      • Memometal Memory Staples (Memoclip – Easy Clip – For Fusion) (K070031) from Memometal
      • ARCAD Compressive Osteosynthesis Staple, EXPRESS Compressive Osteosynthesis Staple (K142111) from Novastep
    • Device Description: Made of NiTi alloy per ASTM F2063.
    • Non-Clinical Tests Performed:
      • Static bending test (ASTM F564 – Annex 4)
      • Dynamic bending test (ASTM F564 Annex 1)
      • Axial pull-out strength (ASTM F564 Annex 2)
      • Transition temperature (ASTM F2004)
      • Corrosion susceptibility testing (ASTM F2129)
      • Cytotoxicity testing (ISO 10993-5:2009)
      • Acute Systemic Toxicity testing (ISO 10993-11:2006)
      • Chemical Characterization (ISO 10993-18:2005)
    • Clinical Test Summary: "No clinical studies were performed."

    Given this, I cannot fill out the requested table or answer the specific questions about clinical study design, acceptance criteria, sample sizes, expert involvement, or ground truth, as that information is not part of this 510(k) submission. This document relies solely on non-clinical (mechanical and biocompatibility) testing to demonstrate substantial equivalence.

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