Search Results

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

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

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

Knee

• Extra-capsular repairs:
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs
  – Vastus medialis obliquous advancement
  Iliotibial band 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

The Smith & Nephew OSTERAPTOR Curved 2.3 Suture Anchor is bioabsorbable 2.3 mm suture anchor manufactured from PLLA/HA and comes preloaded with nonabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter.

This is a 510(k) summary for a medical device (OSTEORAPTOR Curved 2.3 Suture Anchor), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, expert involvement, MRMC studies, and standalone performance is not applicable to this document.

The document states:

• "The performance testing demonstrates that the insertion, pull out and suture slide properties of the OSTEORAPTOR Curved 2.3 anchors are substantially equivalent to the Smith & Nephew OSTEORAPTOR 2.3 anchors."

This indicates that the acceptance criteria for this device were likely based on demonstrations of substantial equivalence in mechanical properties (insertion, pull out, suture slide) compared to a predicate device, as is common for non-AI/ML medical devices seeking 510(k) clearance. However, the exact quantitative acceptance criteria and the detailed study design (e.g., number of samples, test conditions, specific thresholds) are not provided in this summary.

To confirm the mechanical performance, one would typically look for a detailed test report that outlines:

1. Acceptance Criteria: Specific quantitative ranges or values for insertion force, pull-out strength, and suture slippage resistance.
2. Reported Performance: The measured values from the tests.
3. Study Design: Number of samples tested, test apparatus, environmental conditions, and statistical analysis methods.

Ask a specific question about this device