Endotec: orthopaedic & Maxillofacial Implants

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SURGICAL PROCEDURES – ANKLE SYSTEM

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Ankle Sysyem Information:
Ankle SP	Ankle Design Rationale

Indications for Use

DESCRIPTION
The Buechel- Pappas Total Ankle Replacement consists of the following components; a Titanium-Nitride coated, Titanium alloy tibial and talar components, and a UHMWPe bearing.

STERILIZATION
All titanium implant components are provided pre-sterilized by exposure to a minimum of 25 Kilograys of gamma radiation. All UHMWPe components are provided pre-sterilized by exposure to ethylene oxide. If package is damaged, contents should not be used and Endotec, Inc. should be contacted.

INDICATIONS

Patients may have a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis
Patients may have correctable varus or valgus deformity (under 20°)
Patients having intact ankle dorsiflexors and plantarflexors
Patients may have a previous failed total ankle arthroplasty provided the medial and lateral malleoli and ligamentous structures are intact
Viable or reconstructable ligamentous and malleoli supports
Patients may have pseudoarthrosis

CONTRAINDICATIONS

Reduced vascular circulation in the affected limb (e.g. diabetes with peripheral vascular involvement of the foot)
Severe (over 20°) varus or valgus talar tilt
Subjects with distant foci of infection should be treated preoperatively to avoid hematogenous spread of the infection to the implant site
Neuromuscular compromise
Unreconstructable ligamentous or Malleoi supports
Patient in the opinion of the surgeon is extremely obese, and this fact may compromise the function of the device
Is mentally incompetent
Patient has a history of endocrine or metabolic disorder known to affect osteogenesis

PRECAUTIONS
Before clinical use, the surgeon should be familiar with all aspects of the surgical procedure. Patients should be instructed in the limitations of the prosthesis and should be taught to govern their activities accordingly. Sizing between components should only be performed as indicated in the surgical procedures.

WARNINGS
Improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent reduction in the service of the prosthetic implants.

Accepted practices should be followed meticulously in postoperative care and the patient should be made aware of the limitations of total joint reconstruction. Heavy labor, active sports, or other disorders of the hip or knee could increase loading of the ankle and decrease its function.

BIOCOAT® is a registered trademark of Endotec, Inc.
ULTRACOAT® is a registered trademark of Endotec, Inc.
BUECHEL-PAPPAS is a trademark of B-P Trust

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Ankle SP