Apex 3D Total Ankle Replacement System

Multiple implant configurations for size, side, style, and type.

Arc Tibia/Chamfer Talus
Arc tibial tray: designed for rotational stability
Vitamin E cross-linked tibial insert: allows for anatomic conformity
Chamfer-cut talar dome: designed to mimic natural motion
Flat Tibia/Flat Talus
Flat-cut tibial tray
Vitamin E cross-linked tibial insert
Flat-cut talar dome
Color Coded sizing resection blocks

The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

Use of the APEX 3D™ Total Ankle Replacement System is contraindicated in cases of inflammation, cases of active or suspected sepsis/infection and osteomyelitis; or in patients with certain metabolic diseases. All applications that are not defined by the indications are contraindicated.

· This device is not intended for subtalar joint fusion or subtalar joint impingement. Please carefully evaluate the anatomy of each patient before implantation. · The surgeon should discuss with the patient prior to surgery possible risks, precautions, warnings, consequences, complications, and adverse reactions associated with the surgical procedure and implantation of the device. · Improper selection, placement, positioning, and fixation of the prosthetic components may result in unusual stress conditions and a subsequent reduction in service life of the prosthetic component. · Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone. · Re-operation to remove or replace prosthetic components may be required at any time due to medical reasons or device failure. If corrective action is not taken, complications may occur. · Patients need to be informed regarding expectations pertaining to performance and limitations following surgery. The prosthesis does not replace normal bone, has a finite service life, and future revision surgeries may be necessary. Protection of the prosthesis from full weight bearing is needed until adequate fixation and healing is achieved. Certain activities and loading trauma should be limited to prevent unreasonable stresses that could lead to breaking or damage of the prosthetic components. · Do not attempt a surgical procedure with faulty, damaged or suspect instruments or implants. Inspect all components preoperatively to assure utility. · Never modify an implant. · The implants, guide wires, and Laser Alignment Guide are intended for single use only. · Instruments and implants are to be treated as sharps. · Do not implant the instruments. · LASER RADIATION – DO NOT LOOK INTO THE BEAM! Do not look directly with optical instruments into the laser beam apertures, since doing so can be hazardous to your eyes! · The Laser Alignment Guide is not adjustable and maintenance-free. · Use of the Laser Alignment Guide adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. · Use of accessories, transducers and cables other than those specified or provided by the manufacturer of the Laser Alignment Guide could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. · Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Laser Alignment Guide, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. · Do not use other manufacturer’s instruments or implants in conjunction with the APEX 3D™ Total Ankle Replacement Device. · Do not re-sterilize the APEX 3D™ Total Ankle Replacement Implants or Instruments.

In any surgical procedure, the potential for complications and adverse reactions exist. The risks and complications with these prosthetic components include: · Asymptomatic, progressive bone resorption (osteolysis) due to foreign body reaction to particulate matter (See Important Physician Information section for more information) · Sensitivity, allergy or other reactions to prosthetic component materials · Peripheral neuropathies or nerve damage resulting in pain or numbness of the affected limb · Loosening or migration of the prosthetic components · Subluxation or dislocation of the prosthetic components with resulting reduction in range of movement · Bending, disassembly and/or breakage of the prosthetic components · Fractures resulting from unilateral joint loading · Fatigue fracture of the prosthetic components as the result of trauma, strenuous activity, improper alignment, incomplete implant seating, or duration of service · Bone fracture by trauma or excessive loading, particularly in the presence of poor bone stock · Drop in blood pressure intra-operatively due to the use of bone cement · Thrombosis, embolism, or myocardial infarction · Wound hematoma and delayed wound healing · Acute post-operative wound infections and late infections with possible sepsis · Pain, a feeling of malaise or abnormal sensations due to the prosthetic components · Inadequate range of motion due to improper selection or positioning of components or periarticular calcification · Temporary and protracted functional neurological perturbation · Corrosion with localized tissue reaction and pain · Bone loss due to stress shielding · Secondary necrosis of the talus
All possible complications listed here are not typical of Paragon 28®, Inc. products but in principle, may be observed with any total joint replacement implant. Promptly inform Paragon 28®, Inc. as soon as complications occur in connection with the implants or surgical instruments used. In the event of premature failure of an implant in which a causal relationship with its geometry, surface quality or mechanical stability is suspected, please provide Paragon 28®, Inc. with the explant(s) in a cleaned, disinfected and sterile condition. Paragon 28®, Inc. cannot accept any other returns of used implants. The surgeon is held liable for complications associated with inadequate asepsis, inadequate preparation of the osseous implant bed in the case of implants, incorrect indication or surgical technique or incorrect patient information and consequent incorrect patient behavior.