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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
OR
Reference & Predicate Devices
N/A
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.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.