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Parcus SLiK Anchor (English)
1. Indications
The Parcus SLiK Anchors are indicated for attachment of soft tissue to bone. This product is intended
for the following indications:
Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps
Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion
Repair.
Shoulder
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar
Ligament and Tendon Avulsion Repair.
Knee
Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon
Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Foot/Ankle
Tennis Elbow Repair, Biceps Tendon Reattachment.
Elbow
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament
Reconstruction, TFCC.
Hand/Wrist
2. Contraindications
A. Any active infection.
B. Blood supply limitations or other systemic conditions that may retard healing.
C. Foreign body sensitivity, if suspected should be identified and precautions observed.
D. Insufficient quality or quantity of bone. Suture anchor performance is directly related to the quality
of bone into which the anchor is placed.
E. Patient’s inability or unwillingness to follow the surgeon’s prescribed post-operative regimen.
F. Any situation that would compromise the ability of the user to follow the directions for use or using
the device for an indication other than those listed.
3. Adverse Effects
A. Infection, both deep and superficial.
B. Allergies and other reactions to device materials.
C. Risks due to anesthesia.
4. Warnings
A. This product should only be used by or on the order of a physician.
B. The fixation provided by this device should be protected until healing is complete. Failure to follow
the postoperative regimen prescribed by the surgeon could result in the failure of the device and
compromised results.
C. Anchor size selection should be made with care taking into consideration the quality of the bone in
which the anchor is to be placed.
D. Any decision to remove the device should take into consideration the potential risk of a second
surgical procedure. Adequate postoperative management should be followed after implant
removal.
E. The patient should be advised of the use and limitations of this device.