PARCUS MEDICAL V-LoX Instrucciones De Uso página 2

TM
Parcus V-LoX Titanium Suture Anchor
1. Indications
TM
The Parcus V-LoX Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for
the following indications:
Shoulder Rotator Cuff Repair, Acromioclavicular
Separation Repair, Bankart Lesion
Repair, Biceps Tenodesis, Capsular Shift
or Capsulolabral Reconstruction, Deltoid
Repair, SLAP Lesion Repair.
Knee Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair,
Posterior Oblique Ligament Repair, Extra
Capsular Reconstruction, Iliotibial Band
Tenodesis, Patellar Ligament and
Tendon Avulsion Repair.
Foot/Ankle Lateral Stabilization, Medial Stabilization,
Midfoot Reconstruction, Achilles Tendon
Repair, Hallux Valgus Reconstruction,
Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon
Reattachment.
Hand/Wrist Scapholunate Ligament Reconstruction,
Ulnar or Radial Collateral Ligament
Reconstruction, TFCC.
Hip Acetabular Labral Repair
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. Osteopenic bone poses fixation challenges which may be addressed by larger diameter V-LoX Titanium Suture
Anchors.
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. Polyethylene polyblend sutures, as used in this device, elicit a minimal inflammatory reaction in tissues, followed by gradual
encapsulation of the suture by fibrous connective tissue. Polyethylene polyblend suture is not absorbed, nor is any
significant change in tensile strength retention known to occur in vivo.
F. The patient should be advised of the use and limitations of this device.
G. Pre-operative planning and evaluation, surgical approaches and technique, and familiarity of the implant, including its
instrumentation and limitations are necessary components in achieving a good surgical result.
H. This device must never be reused. Reuse or re-sterilization may lead to changes in material characteristics such as
deformation and material degradation which may compromise device performance. Reprocessing of single use devices can
also cause cross-contamination leading to patient infection.
I. This device must never be re-sterilized.
J. Appropriate instrumentation should be used to implant this device.
K. This device has not been evaluated for safety and compatibility in the MR environment. This device has not been tested for
heating or migration in the MR environment. Use of MR technology in the presence of devices of this nature may cause
magnetically induced displacement forces and torques, radio frequency heating and image artifacts. Standard MRI
screening guidelines for post-operative patients should be followed.