Johnson & Johnson DePuy Mitek SPIRALOK, Руководство пользователя

Страница: 2 / 92

1
ENGLISH
SPIRALOK™ Absorbable Threaded
Suture Anchor
Rx Only
DESCRIPTION
The SPIRALOK anchor is a Poly Lactic Acid (PLA)
threaded suture anchor preloaded on a disposable
inserter assembly intended for fixation of two strands
of #2 suture to bone. The ETHIBOND
® Non-Absorbable
Braided Suture, PANACRYL ® Absorbable Braided Suture
and ORTHOCORD™ Braided Composite Suture options
include tapered needles to facilitate suture passage
through tissue. The SPIRALOK anchor is also packaged
without needles for arthroscopic use.
MATERIALS
Handle: ABS
Shaft: Stainless steel
Anchor: PLA absorption is expected to be essentially
complete in four years, D&C blue dye #6.
Suture: See package label for type and number
of strands:
1. PANACRYL‚ Poly (L-Lactide/Glycolide), braided
absorbable suture. PANACRYL sutures meet or
exceed the USP tensile strength requirements
for nonabsorbable and absorbable suture. The
results of implantation studies of PANACRYL
braided absorbable suture in animals indicate
that approximately 80% of its original strength
remains 3 months after implantation. At 6 months
post-implantation, approximately 60% of its original
strength is retained. *
OR
2. ETHIBOND‚ braided polyester, non-
absorbable suture.
OR
3. ORTHOCORD Suture is a synthetic, sterile, braided,
composite suture composed of dyed (D&C Violet #2
or D&C Blue #6) absorbable polydiaxanone (PDS)
and un-dyed non-absorbable polyethylene. The
partially absorbable suture is coated with a copolymer
of 90% caprolactone and 10% glycolide.
The PDS copolymer has been shown to be nonantigenic,
nonpyrogenic and elicits only a slight tissue reaction
during absorption.