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The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.

The Paragon 28 Patient Specific Marking Guides are designed and additively manufactured based on an individual patient's CT scan(s). In surgery, these guides, templates, or anatomical models are used to assist a surgeon in guiding the marking of a bone and/or guiding a surgical instrument for placement (i.e., placing a k-wire). The guides are not used for cutting bone. All guides are patient specific and utilize a CT scanning protocol previously cleared in K180239 (Paragon 28 formerly Additive Orthopaedics). The anatomical landmarks necessary for the design and creation of the Patient Specific Marking Guides must be present and identifiable on computed tomography scan. The Paragon 28 Patient Specific Marking Guides are additively manufactured from biocompatible nylon (PA 2200 - polyamide 12 white) and produced by laser sintering. The Patient Specific Marking Guides are optional for surgeons to help visualize and plan osteotomies in the foot and ankle and are for single use only.

The Additive Orthopaedics 3D Printed Bone Segments are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: *Cotton (opening wedge) osteotomies of the medial cuneiform *Evans lengthening osteotomies The Additive Orthopaedics 3D Printed Bone Segments are intended for use with ancillary plating fixation. The Additive Orthopaedics 3D Printed Bone Segments are not intended for use in the spine. It is a patient specific device.

The Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a simple one piece device constructed individually for each patient using CT image data. It is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The segments are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). It is a patient specific device. The bone segments come in a variety of configurations that depend on the geometry of the application. The surgeon approves the design of the 3D Printed Bone Segments by comparing his/her design requirements to engineering drawings prior to the construction of the implant device.

The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle. The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

The Additive Orthopaedics Bunion System consists of a plate and screws (both locking and nonlocking) with surgical site preparation and insertion instruments. The devices is intended to be used for fixation following an osteotomy in bunion correction procedures. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V). The implants are provided sterile and intended for single use only. The bunion plate comes in 1 individual size and the screws come in 4 lengths.

The Additive Orthopaedics Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

The Additive Orthopaedics Lattice Locking Plates consist of a plate and locking and non-locking screws with surgical site preparation and insertion instruments. It is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The locking lattice plate and screws come in multiple sizes.

The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: *Cotton (opening wedge) osteotomies of the medial cuneiform *Evans lengthening osteotomies The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation. The Additive Orthopaedics Bone Wedges are not intended for use in the spine.

The Additive Orthopaedics Bone Wedge System is a series of wedge-shaped devices intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The wedges are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The wedges come in 18 individual sizes and configurations to correct various skeletal deformities in the foot. The Additive Orthopaedics Bone Wedge System is intended to be used with ancillary plating fixation.

The Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures, and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.

The Additive Orthopaedics Hammertoe Correction System is a monoblock non-circular shaft implant that is cannulated and non-cannulated and incorporates barbs along its longitudinal axis. The system is provided with a drill designed for preparation of the implant site. The implant device, and the drill, are provided in a sterile procedure pack. The implant is intended for single use only and it is available in 0° and 10° configurations. The implant device is additively manufactured from medical grade titanium alloy (Ti-6A1-4V).