Healix Advance Knotless Br Anchor

• 2 recalls, same reason

  • Terminated Z-0666-2020 FDA Class II ·initiated 4 Nov 2019
  • Terminated Z-0665-2020 FDA Class II ·initiated 4 Nov 2019

  Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.

510(k) Number

K130917 ↗

FDA Product Code

MAI

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• OmniSpan Meniscal Repair SYSTEM/0 Degree, Model 228140, RapidLoc A2 Meniscal Repair SYSTEM/12 Degree, Model 228141

  Class II

  FDA 510(k) K092836 Active Cleared 4 Feb 2010

• Rotator Cuff Quickanchor Plus (with Orthocord Suture)

  Class II

  FDA 510(k) K052630 Active Cleared 17 Oct 2005

• Omnicut Resection Blade

  Class II

  FDA 510(k) K130912 Active Cleared 14 Jun 2013

• Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809

  Class II

  FDA 510(k) K103831 Active Cleared 21 Jul 2011

• Milagro Interference Screw

  Class II

  FDA 510(k) K060830 Active Cleared 15 Jun 2006

• Super Quickanchor Plus (with Orthocord Suture)

  Class II

  FDA 510(k) K052631 Active Cleared 21 Oct 2005

See all devices from Depuy Mitek, A Johnson & Johnson Company →