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