Device Description; Indications For Use; Contraindications - Smith & Nephew HEALICOIL PK Mode D'emploi

HEALICOIL™ PK Preloaded
Suture Anchors

Device Description

The Smith & Nephew HEALICOIL™ PK Preloaded Suture
Anchors consist of a non-absorbable suture anchor with
an attached non-absorbable suture assembled to an
insertion device. The suture anchors are intended to
provide secure reattachment of soft tissue to bone.
Attachment of the soft tissue is performed by the
surgeon's preferred technique. The suture anchors
are available in 4.5 mm or 5.5 mm diameters.
These devices are provided sterile, for single use only.
Contents
The suture anchors are packaged in the following
configurations. Refer to the box label for specific
size and configuration.
HEALICOIL PK Suture Anchors contain:
1 ea Non-absorbable suture anchor –
PEEK-OPTIMA
from Invibio
1 ea Insertion device – stainless steel shaft with
polycarbonate and ABS handle
2 or 3 ea Sutures –
braided, uncoated, UHMW polyethylene,
white and/or blue, non-absorbable
and/or
UHMW polyethylene with monofilament
polypropylene cobraid (blue), non-absorbable
and/or
UHMW polyethylene with monofilament nylon
cobraid (black), non-absorbable

Indications for Use

HEALICOIL PK Preloaded Suture Anchors are intended for
use only for the reattachment of soft tissue to bone for the
following indications:
Shoulder
• Bankart lesion repairs
• SLAP lesion repairs
• Acromioclavicular separation repairs
• Rotator cuff tear repairs
• Capsular shift or capsulolabral reconstructions
• Biceps tenodesis
• Deltoid repairs
Foot and Ankle
• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
Elbow
• Ulnar or radial collateral ligament reconstructions
• Lateral epicondylitis repair
• Biceps tendon reattachment
Knee
• Extra-capsular repairs
– Medial collateral ligament
– Lateral collateral ligament
– Posterior oblique ligament
• Iliotibial band tenodesis
• Patellar realignment and tendon repairs
– Vastus medialis obliquous advancement
Hip
• Gluteal tendon repair
– Gluteus medius repair and gluteus minimus repair

Contraindications

• Known hypersensitivity to the implant material. Where
material sensitivity is suspected, appropriate tests
should be made and sensitivity ruled out prior to
implantation.
• Pathological conditions of bone, such as cystic
changes or severe osteopenia, which would
compromise secure anchor fixation.
• Pathological conditions in the soft tissues to be
attached that would impair secure fixation by suture.
• Comminuted bone surface, which would compromise
secure anchor fixation.
• Physical conditions which would eliminate, or tend to
eliminate, adequate anchor support or retard healing,
i.e., limitation of blood supply, infection, etc.
HEALICOIL™ PK Preloaded Suture Anchors
Instructions for Use
MR
(polyetheretherketone)
®
®
English
10600803 Rev. B
3