Publicidad
INDICATIONS
The VERSALOK anchor is indicated for use in the
following procedures for reattachment of soft tissue
to bone:
• Shoulder: Repair of rotator cuff tears and Biceps
Tenodesis.
• K nee: Medial Collateral Ligament Repair, Lateral
Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis, Joint
Capsule Closure
• Elbow: Biceps Tendon Reattachment
CONTRAINDICATIONS
1. P rocedures other than those listed in the
INDICATIONS section.
2. Pathologic conditions of bone such as cystic
changes or severe osteopenia that would impair
its ability to securely fix the VERSALOK anchor.
3. Pathologic changes in the soft tissues being
fixated to bone that would prevent their secure
fixation by the VERSALOK anchor.
4. Comminuted bone surface that would militate
against secure fixation of the VERSALOK anchor.
5. Physical conditions that would eliminate or tend
to eliminate adequate implant support or retard
healing, i.e., blood supply limitation, previous
infection, etc.
6. Conditions which tend to limit the patient's ability
to restrict activities or follow directions during the
healing period.
7. The VERSALOK anchor is not designed for
and should never be used to attach artificial
ligaments.
PRECAUTIONS
1. The VERSALOK anchor is supplied STERILE,
and is intended for single use only. Do not
resterilize. Do not use if sterile packaging
appears to be damaged.
2. The product should be stored under cool, dry
conditions.
3. Inspect all instruments for damage before use. Do
not attempt to repair.
4. A surgeon should not begin clinical use of
the VERSALOK anchor without reviewing the
Instructions for Use and practicing the procedure
in a skills laboratory.
5. Difficulty tensioning sutures may occur as a result
of sutures twisting around anchor, excessive
suture slack around the anchor upon insertion,
malleting the anchor into the bone past the laser
line to the shoulder, and/or immobile Rotator Cuff.
3
Publicidad
