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I. Forefoot System:
The MAXXOS -Forefoot Plating System is "Indicated for Use" in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient.

The Forefoot System is not for Spinal Use.

II. Mid/Hindfoot System:
The MAXXOS - Mid/Hindfoot Plating System is "Indicated for Use" in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.

The Mid/Hindfoot System is not for Spinal Use.

III. Ankle Fracture and Fusion System:
The MAXXOS - Ankle Fracture and Fusion System is "Indicated for Use" in:

1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;

2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the mataphyseal and diaphyseal region of the distal fibula;

3). Fusion of the ankle.

4). In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle.

The Ankle Fracture and Fusion System is not for Spinal Use.

MAXXOS P.A.C.E. Foot & Ankle Plating System consists of Predicate Foot and Ankle Bone Plate and Locking Screw implant components found with many companies with orthopedic markets in the United States. These 'Bone Plate Systems' fracture fixation implant devices consist of the following categories:

1. Forefoot Bone Plate System
2. Mid/ Hindfoot Bone Plate System
3. Ankle Fracture and Fusion System

A brief and concise description of each system is as follows:

1. The MAXXOS Forefoot Bone Plate System is designed to address a variety of indications in forefoot reconstruction fixation surgery. The system is composed of many locking plate types which include:

1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT I Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.8mm, 3.0mm and 3.5mm sizes in various lengths.

All plates are composed of Ti-6Al-4V ELI (ASTM F136) or CP Ti with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) with color anodized for sizing.

A full set of Ancillary Instrumentation (Depth Gauges, Drill Guides, Drill Bits, Reamers, Screwdrivers, Retractors, and Bending Irons) is available with the system, but are not specific to the system.

The MAXXOS Forefoot Bone Plate System is offered both EO 'Sterile' and 'Non-sterile' for single-use.

2. The MAXXOS Mid/Hindfoot Bone Plate System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation surgery. The system is composed of many locking plate types which include: 1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/ Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Rectangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10). Distal Medial & 3/4 Column Plates and 11). ORIF Calcaneal Plates - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths.

All plates are composed of Ti-6Al-4V ELI (ASTM F136) or CP Ti with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) with color anodized for sizing.

A full set of Ancillary Instrumentation (Depth Gauges, Drill Guides, Drill Bits, Reamers, Screwdrivers, Retractors, and Bending Irons) is available with the system, but are not specific to the system.

The MAXXOS Mid/Hindfoot Bone Plate System is offered both EO 'Sterile' and 'Non-sterile' for single-use.

3. The MAXXOS Ankle Fracture and Fusion System is designed to address a variety of indications in ankle reconstruction distal tibia/ fibula fixation surgery. The system is composed of many locking plate types which include:

1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates - in various plate lengths, Right & Left versions, 7) Tibia Fusion Plates- in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths.

All plates are composed of Ti-6Al-4V ELI (ASTM F136) or CP Ti with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) with color anodized for sizing.

A full set of Ancillary Instrumentation (Depth Gauges, Drill Guides, Drill Bits, Reamers, Screwdrivers, Retractors, and Bending Irons) is available with the system, but are not specific to the system.

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