BIORAPTOR 2.3 PK SUTURE ANCHOR

• K Number: K071586
• Device Name: BIORAPTOR 2.3 PK SUTURE ANCHOR
• Manufacturer: SMITH & NEPHEW INC., ENDOSCOPY DIVISION
• Date Cleared: 2007-08-17 ( 67 days)
• Product Code: MBI
• Regulation Number: 888.3040
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K063726 , K061154

Intended Use

The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Elbow, Wrist, and Hand
Biceps tendon reattachment
Lateral epicondylitis repair
Ulnar or radial collateral ligament reconstructions

Knee
Extra-capsular repairs: - Medial collateral ligament

• Lateral collateral ligament
• Posterior oblique ligament
  Iliotibial band tenodesis
  Patellar realignment and tendon repairs
• Vastus medialis obliquous advancement

Hip
Hip capsule repair

• Acetabular labrum reattachment

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
  Acromioclavicular separation repairs
  Deltoid repairs
  Rotator cuff tear repairs
  Biceps tenodesis

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

Device Description

Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with attached non-bioabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a stainless steel inserter.

AI/ML Overview

The provided text is a 510(k) summary for the BIORAPTOR PK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, particularly material composition. It does not contain the kind of detailed information about acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC, standalone) that your request outlines.

Therefore, I cannot extract the requested information from the provided text. The document states:

• "The performance testing conducted demonstrates that the insertion and fixation properties of the BIORAPTOR PK anchor are substantially equivalent to the Smith & Nephew BIORAPTOR OC and the Smith & Nephew KINSA anchors."

This is a general statement of equivalency based on performance testing, but it does not provide the specific data points, acceptance criteria, or methodological details required to answer your questions comprehensively.

In summary, the document does not contain the information needed to fill out your request.

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.