(41 days)
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction
• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair,
Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament
Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of
Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits,
Digital Tendon Transfers
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon
Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital
Tendon Transfers, Mid-foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular Repair, Acetabular Labral repair
The Arthrex Knotless SutureTak Anchor is a non-absorbable, "tap-in" suture anchor with a ribbed profile and a proximally placed external suture eyelet. The anchor is manufactured of Polyetheretherketone (PEEK) and is preloaded with Arthrex Suture and is offered preassembled on a driver. The anchor was originally cleared under K120155 for indications in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
This document describes the Arthrex Knotless SutureTak Anchor, a medical device. Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull-out Strength | Statistically equivalent to the predicate device (DePUY Mitek VERSALOK Anchor). |
| Pyrogenicity (Bacterial Endotoxin) | Device meets pyrogen limit specifications (per EP 2.6.14/USP ). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the pull-out test.
The provenance of the data (country of origin, retrospective/prospective) is also not specified. It is an in-vitro performance test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study involves performance testing of the device's mechanical and biological properties, not a diagnostic or AI-driven evaluation that requires expert ground truth assessment.
4. Adjudication Method
This information is not applicable for this type of device performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a medical device (suture anchor) and not an AI-driven diagnostic tool. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a medical device, not an algorithm.
7. Type of Ground Truth Used
For the pull-out test, the "ground truth" is established by the performance of the chosen predicate device (DePUY Mitek VERSALOK Anchor), against which the Arthrex Knotless SutureTak Anchor is compared for statistical equivalence.
For the pyrogenicity test, the "ground truth" is defined by the pyrogen limit specifications outlined in EP 2.6.14/USP .
8. Sample Size for the Training Set
This information is not applicable. This is a medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
§ 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.