Intended Use; Indications For Use - ConMed CrossFT Manual Del Usuario

ENGLISH/INSTRUCTIONS FOR USE
MATERIAL SPECIFICATIONS
Anchor: Polylactide copolymer (96L/4D PLA co-polymer) and beta-tricalcium phosphate (β-TCP)
Driver Shaft/Body: Stainless Steel
Driver Handle: Polycarbonate
Suture: Hi-Fi non-absorbable braided #2 (5 metric), ultra-high molecular weight polyethylene
®
Suture: Hi-Fi non-absorbable Tape, ultra-high molecular weight polyethylene with polyester
®
Suture: Hi-Fi non-absorbable Tape, ultra-high molecular weight polyethylene with nylon
®
Threader: Nitinol
Suture
Hi-Fi non-absorbable braided #2 (5 metric), ultra-high
®
molecular weight polyethylene
Hi-Fi Tape, ultra-high molecular weight polyethylene with
®
polyester, or nylon

INTENDED USE

The biocomposite suture anchor is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:

INDICATIONS FOR USE

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it
may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system
thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the
healing period.
CONTRAINDICATIONS
1. Pathological conditions of bone which would adversely affect the CrossFT™ Knotless Biocomposite Suture Anchor.
2. Pathological conditions in the soft tissue to be repaired or reconstructed which would adversely affect suture fixation.
3. Physical conditions that would eliminate, or tend to eliminate, adequate implant support or retard healing.
4. Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the
healing period.
5. Attachment of artificial ligaments or other implants.
6. Foreign body sensitivity, known or suspected allergies to implant and/ or instrument materials.
7. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical,
thoracic or lumbar spine.
WARNINGS
1. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and
placement of the implant are important considerations in the successful utilization of this device. Surgeon must
choose proper implant size based on specific procedure and patient history.
2. Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical
procedure. Implant removal should be followed by adequate postoperative management.
3. Do not use beyond the expiration date listed on the label. The performance, safety, and/or sterility of the device
cannot be assured beyond the expiration date.
4. Remove items from the sterile package using aseptic techniques.
5. Detailed instructions on the use and limitations of the device should be given to the patient. The patient should be told
to follow the surgeon's protocol for postoperative management.
6. Patient should be advised that product materials may cause allergic reactions including but not limited to, foreign body
reaction, tissue irritation/inflammation or other allergic reactions. Where material sensitivity is suspected, appropriate
tests should be made and sensitivity ruled out prior to implantation.
Procedure
Rotator cuff repair
Achilles Repair
Biceps Tenodesis
Gluteus Medius Repair
Medial Patellofmoral Ligament (MPFL)
2
Average Size (mm)
0.500 - 0.630 diameter
2 width
Joint
Shoulder
Ankle
Shoulder
Hip
Knee