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510(k) Data Aggregation

    K Number
    K981798
    Device Name
    LACTOSORB POP RIVET
    Manufacturer
    BIOMET, INC.
    Date Cleared
    1998-07-13

    (53 days)

    Product Code
    JDR,HRX,MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LACTOSORB POP RIVET

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

    The LactoSorb®Pop Rivet are indicated for use in soft tissue reattachment in the following shoulder procedures:

      1. instability repairs in the shoulder (Bankart procedures)
      1. SLAP lesion repair
      1. Acromio-clavicular separation repairs
      1. Rotator cuff repairs
      1. Capsular shift or capsulolabral reconstructions
      1. Biceps tenodesis
      1. Deltoid repair
    Device Description

    The LactoSorb* Pop Rivets are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb* resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb* has been found to be biocompatible in both soft tissue and bone tissue.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called the LactoSorb® Pop Rivet. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI-related performance metrics.

    The summary primarily focuses on:

    • Device Name and Manufacturer: LactoSorb® Pop Rivet by Biomet, Inc.
    • Indications for Use: Soft tissue reattachment in various shoulder procedures (Bankart, SLAP, AC separation, rotator cuff, capsular shift, biceps tenodesis, deltoid repair).
    • Device Composition: Bioresorbable and biocompatible polymers (polylactic/polyglycolic acid copolymer).
    • Mechanism of Degradation: Hydrolyzes to lactic and glycolic acids, which are then metabolized.
    • Biocompatibility: Stated to be biocompatible in soft tissue and bone tissue based on animal studies.
    • Substantial Equivalence: Claim that it does not raise new safety or effectiveness concerns compared to the predicate device.
    • FDA 510(k) Clearance: Letter from the FDA confirming substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, or AI-related metrics as this information is not present in the provided document.

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