Maa: Valko-Venäjä
Kieli: venäjä
Lähde: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Medos International SARL, ШВЕЙЦАРИЯ
изделия медицинского назначения
Medos International SARL
2020-10-02
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. 3 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 Lue koko asiakirja