Subchondral Solutions Cleared IFU for Screw Indication - K220901

Subchondral Solutions Cleared IFU for Screw Indication - K220901

March 24, 2023

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Reviewed by: Derek Dee, MD, Huntington Beach, CA

The S-Core Implant System (6.0mm – 10.0 mm diameter) is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio- Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. Hip: Capsular repair, acetabular labral repair, gluteus medius repair.

Refer to the S-Core Implant System and S-Fibre Suture instructions for use.

A description of the screw implantation as a suture anchor is provided in the follow steps.

  1. The surgical site is exposed and prepared for fixation utilizing the surgeon’s preferred technique. Based on preference, bone size, location and indication, choose between the available diameters of cannulated screws.
  2. View from the top of the Implant, showing fenestrations to be used for suture attachment.
  3. View from the bottom of Implant, fenestrations to be used for suture attachment.
  4. Using the Subchondral Solutions S-Fibre™ Suture, insert the needles from the bottom of implant (Note: Suture is colored green for illustrative purposes only).
  5. Insert needles through adjacent holes on implant.
  6. Pull suture through until tight
  7. Suture secured, bottom view
  8. Introduce the Guidewire with the Drill Guide at the entry point of the screw. Confirm the accurate wire placement position and appropriate depth under fluoroscopy. Correct Guidewire placement is important because this determines the trajectory of the screw. Note: The initial insertion of the Guidewire should be placed in a depth slightly longer than the Countersink and the Cannulated Drill depth without violating the far cortex to prevent accidental withdrawal of the Guidewire.
  9. Measure the initial guidewire length using the Depth Gauge. It may be necessary to subtract from the length if the desired screw placement is to be buried beneath the bone surface. Correct guidewire length is important because this determines the length of the screw.
  10. After measuring the appropriate screw depth, advance the guidewire further to minimize the risk of accidental withdrawal of the guidewire while drilling. Confirm position under fluoroscopy.
  11. Insert appropriate countersink sheath diameter and obturator over guidewire.

12. Remove Obturator. Install appropriate Countersink over Guidewire. Drill until stop on Countersink Sheath. Remove Countersink and Sheath.

13. Insert appropriate Cannulated Drill Sheath diameter and Obturator over Guidewire.

14. Remove Obturator. There are multiple length Cannulated Drills per Screw diameter. Insert proper length Cannulated Drill matching the Screw Length from above. Place over Guidewire. Drill until stop on Cannulated Drill Sheath. Remove Cannulated Drill and Sheath.

15. Insert S-Core Implant on Hexalobe Driver.

16. Insert S-Core Implant and Hexalobe Driver over Guidewire and screw in until the desired location is achieved in the bone. Confirm position with fluoroscopy.

17. Confirm placement and length of the S-Core Implant on imaging, ensuring that both leading and trailing edges of the S-Core Implant are placed beneath the surface. Remove the Guidewire.

18. Remove Driver and tie suture to soft tissue.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Disclaimer: This procedure guide does not replace the instruction for use for the S-Core Implant System. The instructions for use provided in the product packaging should be followed stringently. It is the responsibility of the use to perform the S-Core System procedure according to the instruction for use.

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