Werbung
Verfügbare Sprachen
Verfügbare Sprachen
DESCRIPTION
The ConMed Linvatec GENESYS™ CrossFT™ (biocomposite) Suture Anchors are manufactured from polylactide
copolymer (96L/4D PLA co-polymer) and beta-tricalcium phosphate(-TCP). The GENESYS CrossFT Suture
Anchors are provided sterile, preloaded on a single-use driver and pre-threaded with two or three #2 (5 metric) Hi-
®
Fi
Sutures with or without needles.
Material Specifications
Anchor: polylactide copolymer (96L/4D PLA) and beta- tricalcium phosphate (-TCP)
Driver Shaft/Body: Stainless Steel
Driver Handle: Polycarbonate
Suture: Hi-Fi non-absorbable braided #2 (5 metric), ultra-high molecular weight polyethylene with polypropylene
Suture: Hi-Fi non-absorbable braided #2 (5 metric), ultra-high molecular weight polyethylene with nylon
Suture: Hi-Fi non-absorbable braided #2 (5 metric), ultra-high molecular weight polyethylene
Suture: Hi-Fi non-absorbable braided #2 (5 metric), ultra-high molecular weight polyethylene with polyester
Needle: Stainless steel
Hi-Fi non-absorbable braided #2 (5 metric), ultra-high molecular weight polyethylene with
Nylon, or Polypropylene or Polyester
INTENDED USE
The ConMed Linvatec GENESYS CrossFT Suture Anchors are intended to reattach soft tissue to bone in orthopedic
surgical procedures.
INDICATIONS FOR USE
The ConMed Linvatec GENESYS CrossFT Suture Anchors are intended to reattach soft tissue to bone in orthopedic
surgical procedures. The system 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.
These devices are contraindicated for the following indications:
ACL (Anterior Cruciate Ligament), PCL (Posterior Cruciate Ligament), foot, and hand procedures
CONTRAINDICATIONS
1.
Pathological conditions of bone which would adversely affect the GENESYS CrossFT 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.
Suture
2
Average Diameter (mm)
0.500 - 0.630
Werbung
