ENGLISH
TRUESPAN
Meniscal
™
Repair System
DESCRIPTION
The TRUESPAN
Meniscal Repair System consists of
™
a sterile disposable applier preloaded with a backstop
assembly and needle. The applier introduces the
backstop assembly into the meniscus. The backstop
assembly is composed of sutures and two molded
implants. The sutures and implants re-approximate or
fixate soft tissue of the meniscus.
A malleable graft retractor, or slotted cannula, and an
arthroscopic pusher/cutter are used in conjunction
with the system. These are general instruments, and
are sold separately.
SYSTEM MATERIALS
Backstop Assembly: PEEK or PLGA implants
with size 2/0 ORTHOCORD
Suture and ultra-high
®
molecular weight polyethylene (UHMWPE) suture.
ORTHOCORD Suture is a synthetic, braided,
composite suture composed of dyed (D&C Violet #2)
absorbable polydioxanone (PDS
) and un-dyed
®
non-absorbable polyethylene. The partially absorbable
suture is coated with a copolymer of 90% caprolactone
and 10% glycolide.
Applier: Polycarbonate, ABS, fluorinated ethylene
propylene (FEP), silicone, nylon, and stainless steel.
INDICATIONS
The TRUESPAN Meniscal Repair System is intended
for use in meniscal repairs and meniscal allograft
transplant procedures. The TRUESPAN Meniscal
Repair System is intended to be used for anchoring
the allograft to the meniscal rim during allograft
transplant procedures.
CONTRAINDICATIONS
• Do not use for surgery other than those indicated.
• Pathological conditions in the tissue which would
impair secure fixation by suture.
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