Фиксаторы имплантируемые для проведения артроскопических операций:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Medos International SARL, ШВЕЙЦАРИЯ

класс:

изделия медицинского назначения

Производитель:

Medos International SARL

Дата Авторизация:

2020-10-02

Характеристики продукта

HEALIX ADVANCE
™
KNOTLESS
SUTURE ANCHOR
P/N: 116046
REV: B ISSUED 12/2019
© DEPUY SYNTHES 2018-2019.
ALL RIGHTS RESERVED.
2
ENGLISH
HEALIX ADVANCE
™
KNOTLESS
SUTURE ANCHOR
CONTENTS
Contents are STERILE unless packaging is damaged
or opened.
DESCRIPTION
The HEALIX ADVANCE™ KNOTLESS Anchors are
one piece implants, consisting of either:
• PEEK (Polyetheretherketone)
OR
• BIOCRYL RAPIDE™ (BR), an absorbable
composite material (PLGA/TCP).
See package label for anchor material.
The HEALIX ADVANCE KNOTLESS Anchors are
sterile implants designed to secure soft tissue to bone
when used in conjunction with high-strength #2 suture
or PERMATAPE™ 2.5mm suture.
MATERIALS
Anchor: BIOCRYL RAPIDE (BR) or PEEK
(Polyetheretherketone)
Shaft: Stainless steel
Handle: Acrylonitrile Butadiene Styrene (ABS)
Driver Collar: ABS
Threader Tab: Polycarbonate and stainless steel
Stay Suture: Orthocord
®
Suture is a synthetic, sterile,
braided, composite suture composed of dyed (D&C
Violet #2 or D&C Blue #6) absorbable polydioxanone
(PDS
®
) and un-dyed non-absorbable polyethylene.
The partially absorbable suture is coated with a
copolymer of 90% caprolactone and 10% glycolide.
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INDICATIONS
The HEALIX ADVANCE KNOTLESS Anchors are
indicated for use in the following procedures for
reattachment of soft tissue to bone:
Indication
BR
PEEK
Shoulder
Rotator Cuff
X
X
Biceps Tenodesis
X
X
Deltoid Repair
X
X
Foot/Ankle
Achilles Tendon
X
X
CONTRAINDICATIONS
• Procedures other than those listed in the
INDICATIONS section.
• Pathologic conditions of bone such as cystic
changes or severe osteopenia that would impair
its ability to securely fix the HEALIX ADVANCE
KNOTLESS Anchors.
• Pathologic changes in the soft tissues being fixated
to bone that would prevent their secure fixation by
the HEALIX ADVANCE KNOTLESS Anchors.
• Comminuted bone surface that would militate
against secure fixation of the HEALIX ADVANCE
KNOTLESS Anchors.
• Physical conditions that would eliminate or tend
to eliminate adequate implant support or retard
heali