LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021828
    Device Name
    SMALL HAMMER TOE PIN
    Manufacturer
    BIOMET, INC.
    Date Cleared
    2002-07-01

    (27 days)

    Product Code
    HWC,87H
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011137
    Predicate For
    K100414
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.

    Device Description

    The Small Hammer Toe Pin is made out of the oriented Lactosorb® material and is indicated for proximal interphalangeal joint (PIP) joint arthrodesis. LactoSorb® is a polyester derivative of L-Lactic and glycolic acids. Poly Llactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into Llactic and glycolic acids, which are then metabolized by the body. The device has threads on one end and barbs on the other.

    AI/ML Overview

    The provided document is a 510(k) premarket notification summary for a medical device (Small Hammer Toe Pin). It does not contain any information about acceptance criteria, device performance metrics, or the details of a study that would prove the device meets such criteria.

    Instead, the document focuses on:

    • Device identification: Proprietary name, common name, classification, product code, and predicate device.
    • Intended Use: Proximal interphalangeal (PIP) joint arthrodesis.
    • Device Description: Material (Lactosorb® - a resorbable polymer), and physical features (threads on one end, barbs on the other).
    • Non-Clinical Testing: Mentions that non-clinical testing "demonstrated statistical equivalence between this device and the predicate." However, it does not provide any specific acceptance criteria or results of this testing.
    • Clinical Testing: Explicitly states, "Clinical testing was not used to establish substantial equivalence." This means there's no clinical study described in this document to evaluate the device's performance against acceptance criteria.
    • FDA determination: A letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device. This is a regulatory finding for market clearance, not an evaluation of performance against specific acceptance criteria.

    Therefore, I cannot provide the requested information for acceptance criteria and study details because it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1