Idiomas disponibles
Idiomas disponibles
Parcus Graft Fixation System Naked Product Family (English)
1. Indications:
The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in
patients requiring ligament or tendon 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.
E. Patient's inability or unwillingness to follow 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.
G. The GFS Naked devices are intended to be used in conjunction with a suture product such as #2
or #5 Parcus Braid Suture which is ultra high-strength, braided, polyethylene polyblend sutures.
Use of this device with other types or sizes of suture products may lower the ultimate strength of
the device which could compromise the overall fixation. Implant size and suture selection is at
the discretion of the surgeon and should be based on the expected forces that the fixation is
intended to withstand.
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. Caution: Federal law restricts this device to sale 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. Size selection of the implant and suture should be made with care taking into consideration the
quality of the bone on which the implant will rest and the anticipated forces that the fixation must
resist.
D. Any decision to remove the device should take into consideration the potential risk of a second
surgical procedure. An adequate postoperative management plan should be implemented after
implant removal.
E. 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.
F. 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.
G. This device must never be re-sterilized.
H. Appropriate instrumentation should be used to implant this device.
