Device Description; Indications For Use; Contraindications - smith&nephew FOOTPRINT Ultra PK Mode D'emploi

FOOTPRINT Ultra
PK Suture Anchor

Device Description

The Smith & Nephew FOOTPRINT Ultra PK (PEEK-OPTIMA
from Invibio
®
to an insertion device, and available in 4.5 mm and
5.5 mm. The suture anchor is intended to provide secure
reattachment of soft tissue to bone. Attachment of the soft
tissue is performed by the surgeon's preferred technique.
This device is provided sterile, for single use only.
Contents
The FOOTPRINT Ultra PK Suture Anchor contains:
1 ea. Non-absorbable suture anchor –
PEEK-OPTIMA from Invibio.
1 ea. Insertion device – stainless steel shaft
with polycarbonate and ABS handle, and
a thermoplastic elastomer suture threader.
1 ea. Retention suture – braided polyester
non-absorbable suture (USP #2-0).

Indications for Use

Smith & Nephew FOOTPRINT Ultra PK Suture Anchors are
intended for use only for the reattachment of soft tissue to
bone for the following indications:
Shoulder
• 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
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

Contraindications

• Known hypersensitivity to the implant material. Where
material sensitivity is suspected, appropriate tests
should be made and sensitivity ruled out prior to
implantation.
• Surgical procedures other than those listed in the
Indications for Use section.
• 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.
Warnings
Do not use if package is damaged. Do not use if
the product sterilization barrier or its packaging
is compromised.
• Contents are sterile unless package is opened or
damaged. DO NOT RESTERILIZE. For single use only.
Discard any open, unused product. Do not use
after the expiration date.
• It is the surgeon's responsibility to be familiar with
the appropriate surgical techniques prior to use of
this device.
• Read these instructions completely prior to use.
• Incomplete anchor insertion may result in poor
anchor performance.
• Breakage of the suture anchor can occur if
insertion sites are not properly prepared prior
to implantation.
• Do not attempt to implant this device within
cartilage epiphyseal growth plates or non-osseous
tissue.
FOOTPRINT Ultra PK Suture Anchor
Instructions for Use
) Suture Anchor is non-absorbable, attached
English
®
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