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K Number
K171114
Device Name
HEALIX ADVANCE KNOTLESS Anchor
Manufacturer
Medos International SARL
Date Cleared
2017-11-27

(227 days)

Product Code
MAI,MBI
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K130917,K131974,K130539,K131683,K101679,K082810,K071177,K061863,K051219
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HEALIX ADVANCE KNOTLESS Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

Foot/Ankle*: Achilles Tendon Repair
*HEALIX ADVANCE KNOTLESS PEEK Anchors only

Device Description

The HEALIX ADVANCE™ KNOTLESS Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE™ KNOTLESS Anchors are molded from Biocryl Rapide® (BR) and polyetheretherketone (PEEK) materials. The HEALIX ADVANCE™ KNOTLESS Anchor is provided sterile and is for single use only.

AI/ML Overview

The provided text describes a medical device, the HEALIX ADVANCE™ KNOTLESS Anchor, and its substantial equivalence to predicate devices. It focuses on the device's design, materials, and clinical indications for use, as well as the non-clinical testing performed.

However, the document does not contain information related to an AI/ML device. Therefore, I am unable to provide a response to your request, as it specifically asks for acceptance criteria and study details for a device supported by AI/ML.

The text discusses:

  • Device Name: HEALIX ADVANCE™ KNOTLESS Anchor
  • Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
  • Regulatory Class: Class II
  • Product Codes: MAI, MBI
  • Indications for Use: Reattachment of soft tissue to bone in procedures involving the shoulder (Rotator Cuff, Biceps Tenodesis, Deltoid Repair), knee (Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis), and Foot/Ankle (Achilles Tendon Repair - PEEK Anchors only).
  • Non-clinical Testing: In-vitro anchor pull out, time zero anchor pull out, torque testing, biological, sterility, packaging, and shelf-life evaluations.

This information pertains to a physical medical implant and its mechanical performance, not to an AI/ML diagnostic or predictive tool.

§ 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.