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K Number
K193245
Device Name
Dunamis PunchTac Suture Anchors
Manufacturer
Dunamis LLC
Date Cleared
2020-02-14

(81 days)

Product Code
MBI
Regulation Number
888.3040
Type
Special
Panel
OR
Reference & Predicate Devices
K082215,K112526,K160996
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Dunamis PunchTac Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications:

  • Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
    Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Achilles tendon repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/ tendon repairs/ reconstructions Bunionectomy

Knee

Extra-capsular repairs: medial collateral ligament, lateral ligament, posterior oblique ligament

Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis

Hip

Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm - 6.5mm)

Device Description

The Dunamis PunchTac Suture Anchors is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components:

  • Suture Anchor (threaded, push-in and knotless designs)
  • . USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene Suture(s) or Suture Tape (provided in configurations with suture only)
  • . Inserter Tool
AI/ML Overview

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Dunamis LLC for their PunchTac Suture Anchors.

It primarily details:

  • The FDA's determination of substantial equivalence for the Dunamis PunchTac Suture Anchors to legally marketed predicate devices.
  • The regulatory classification and product codes for the device.
  • The intended indications for use of the suture anchors.
  • A brief description of the device components.
  • The predicate devices used for comparison.
  • Statements indicating that testing was performed (pull-out strength and insertion testing) and that the device met "pre-determined acceptance criteria identified in the Design Control Activities" and LAL testing requirements. However, it does not specify what those acceptance criteria were, what the reported performance was, or provide details about the study itself.

Therefore, I cannot provide the requested information from this document.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.