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Designed to address inherent challenges associated with total ankle joint replacement including: Implant loosening, pathological wear, instability and persistent pain.

The APEX 3D™ Total Ankle Replacement System (APEX 3D™ System) marks the next generation in total ankle arthroplasty, with advanced technologies and a keen eye towards optionality. The APEX 3D™ System is the newest addition to the Paragon 28® Precision Ankle Solutions portfolio of products and complements the Gorilla® Ankle Fracture Plating System, Silverback® Fusion Plating System, Phantom™ Hindfoot TCC and ActivCore™ Nail Systems.

APEX 3D™ Total Ankle Replacement System

The APEX 3D™ System consists of cemented, fixed bearing, anatomically contoured implant components, intuitive instrumentation and precision bone resection guides intended for use in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery is also indicated when sufficient bone stock is present. Components are intended for cemented use only. For additional information regarding Indications for Use, Contraindications, Warnings, Precautions, etc. please visit: Paragon28.com/ifus/.

The APEX 3D™ System has been efficiently streamlined to accommodate surgeon preference and is equipped to address a wide range of arthritic ankle conditions. The APEX 3D™ System is based on over a century of combined clinical experience, cuttingedge biomechanical research, and designed to address inherent challenges associated with total ankle joint replacement clinical outcomes including:

Implant loosening
Pathological wear
Instability
Persistent pain

The APEX 3D™ System offers surgeons: four targeted bone preparation options, including interchangeable configurations such as ARC Tibia™ or Flat tibia with either Chamfer or Flat talus preparation options and provides coupled or decoupled bone resection options to accommodate individual patient condition types.

Tibial and Talar Implant designs are based on pre-clinical arthritic tibiotalar morphological studies and guided by healthy ankle weight-bearing CT research. Anatomically contoured 3D printed tibial tray implants with porous architecture and gradient zones down to solid titanium substrate are available in two distinct geometric style options including ARC Tibia™ or Flat. Offered in left and right configurations, available in short*, standard and long lengths for optimal posterior bone coverage and AP fit to reduce the potential for subsidence. The tibial implants feature two non-coated vertical pegs for initial stabilization. The pegs are positioned slightly posterior to midline where peak bone density is located1, which provide a broad anterior surface area to optimize the contact interface.

The cross-linked polyethylene tibial insert is infused with Vitamin E to reduce oxidation, wear debris, and potential for osteolysis.2,3 The design features a universal locking mechanism that allows for additional intraoperative implant optionality and a semi-constrained bicondylar design that allows for anatomic conformity. Vitamin E polyethylene components are available in primary and revision thicknesses.

Two distinct Talar Dome style options are offered (Chamfer and Flat) in left and right configurations, featuring tapered shoulders designed to reduce potential for painful gutter impingement, a gentle sulcus and multi-axial articulation that helps to mimic natural motion.

Tibial Trays

Geometric low-profile tibial trays were designed to provide rotational stability and reduce potential for component loosening.

3D Printed additive metal technology for optimal porosity

Low-profile geometric ARC Tibia™ architecture designed for rotational stability

Two vertical pegs positioned slightly posterior to midline where peak bone density is located for initial fixation and stabilization

Vitamin E Tibial Poly Insert

The APEX 3D™ Total Ankle Replacement System’s polyethylene implant features Vitamin E technology for enhanced wear characteristics.

Vitamin E cross-linked infusion to reduce oxidation, wear debris and potential for osteolysis

Universal locking mechanism allows for increased implant sizing optionality

Semi-constrained bicondylar bearing surface allows for natural anatomic conformity

Talar Domes

Based on arthritic ankle morphology and tibiotalar motion during simulated gait using modern weight-bearing CT technology.

Anatomically contoured curvature based on arthritic ankle morphology to optimize talar bone coverage

From early-stance to late-stance, multi-axial articulation conforms to natural tibiotalar motion and reduces the potential for bony and component impingement