Johnson & Johnson DePuy Mitek OMNISPAN Handbuch Seite 2

ENGLISH
OMNISPAN™ Meniscal Repair System
CONTENTS
Contents are STERILE unless packaging is damaged
or opened. Resterilization by any method is not
recommended.
DESCRIPTION
The OMNISPAN™ Meniscal Repair System consists
of the OMNISPAN backstop implants and needle, a
sterile, disposable Deployment Gun, Malleable Graft
Retractor, and the Arthroscopic Pusher/Cutter. The
OMNISPAN backstop implant is a combination of
two molded Polyetheretherketone (PEEK) implants,
combined with ORTHOCORD violet braided
®
composite suture, Size 2/0. The molded implants
together with the suture provide compression across
the tear in the meniscus. The Deployment Gun properly
introduces the implant into the meniscus and the
Pusher/Cutter facilitates the final suture position flush
with the meniscal surface.
SYSTEM MATERIALS
Backstops: Polyetheretherketone (PEEK)
Suture: ORTHOCORD violet braided composite
suture, Size 2/0. ORTHOCORD Suture is a synthetic,
sterile, braided, composite suture composed of dyed
absorbable polydiaxanone (PDS®) and undyed non-
absorbable polyethylene. The partially absorbable
suture is coated with 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.
Needles: Stainless Steel with Silicone Tubing
Meniscal Deployment Gun: Polycarbonate, ABS,
Ultem, and Stainless Steel (sold separately – covered
by this IFU)
Malleable Graft Retractor: Stainless steel sold
separately with the Meniscal Deployment gun –
covered by this IFU).
Arthroscopic Pusher/Cutter: Stainless steel and
aluminum (sold separately).
Note: The Arthroscopic Pusher/Cutter is provided
non-sterile. Cleaning and sterilization instructions are
covered by its own IFU that is packaged with it.
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