TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318

• K Number: K031685
• Device Name: TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
• Manufacturer: SMITH & NEPHEW, INC.
• Date Cleared: 2003-07-01 ( 29 days)
• Product Code: HWC , GAS , JDR
• Regulation Number: 888.3040
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K961555

Intended Use

Intended Use: Reattachment of soft tissue to bone

Indications for Use :

1. Bankart Lesion Repair
2. Rotator Cuff Repair
3. Capsular Stabilization
4. Anterior Shoulder Instability Repair
5. Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of:

• Bunionectomy -
• Lateral ankle instability -
• Biceps tendon reattachment -

Device Description

The Tag Rod BioRaptor 2.9 mm suture anchor is a push-in bioabsorable device utilized for the reattachment of soft tissue to bone.

AI/ML Overview

This document is a 510(k) summary for a medical device (Tag Rod BioRaptor™ Suture Anchor) and does not contain information about acceptance criteria or a study demonstrating the device meets those criteria.

This type of submission focuses on demonstrating substantial equivalence to a previously approved predicate device, rather than proving performance against specific acceptance criteria through a clinical or performance study.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. This information is typically found in a clinical study report or a more detailed device performance evaluation, neither of which is present here.

Regulation Number and Section

§ 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.