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Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments. Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.

The Prophecy® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Preoperative Navigation Alignment Guides and Reports are intended for use with the Inbone®, Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Prophecy® Preoperative Navigation Alignment Guides are intended for single use only.

The Prophecy® Preoperative Navigation Alignment System is composed of three components: - Prophecy® patient-specific guides - Prophecy® 3D Planner - Prophecy® Preoperative report The Prophecy® Preoperative Navigation Alignment guides are patient-specific devices that are designed based on preoperative planning software and assist surgeons in transferring their preoperative plan to surgery by guiding the marking of bone and/or guiding surgical instruments. The Prophecy® 3D Planner software is a web-based application. The user interface software is intended to be used by orthopedic surgeons, as a preoperative planning and intraoperative viewing software for total ankle replacement surgery. The Prophecy® Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and offers relevant information for a successful total ankle replacement surgery. The Prophecy® Preoperative Navigation Alignment System is compatible with the Inbone™, InfinityTM, and Invision™ Total Ankle Systems.

PRO-DENSE LoVisc™ resultant pastel is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the sketal system (i.e., the extremities, and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The PRO-DENSE LoVisc™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. PRO-DENSE LoVisc™ is provided sterile for single use only.

PRO-DENSE LoVisc™ Bone Graft Substitute is a calcium sulfate formulation consisting of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.

The PHALINX™ Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated Implants in the PHALINX™ Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a gamma sterilized version of the PHALINX Hammertoe system. The subject PHALINX® Hammertoe System implants are designed to facilitate fixation of osteotomies and reconstruction of the lesser toes. The implants have barbed proximal and interrupted distal threads fixation features and are offered in multiple sizes. The subject PHALINX hammertoe implant is single piece titanium device offered in straight cannulated and angled 10° solid options and remains identical to the predicate in design. The subject cannulated hammertoe implanted temporarily with k-wires (0.9, 1.1, 1.4 mm) to stabilize outlying joints. These k-wires were originally cleared under K 142585 and a minor modification to the length of the k-wire is being made in this submission.

Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The PROPHECY™ Preoperative Navigation Alignment Guides and Reports are intended for use with Wright's INBONE™, INFINITY™ and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for single use only.

The PROPHECY™ Preoperative Navigation Alignment System is composed of two components: - . PROPHECY™ Preoperative report - . PROPHECY™ patient-specific guides The PROPHECY™ Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and information relevant to the successful implantation of a total ankle replacement. The PROPHECY™ Preoperative Navigation Alignment guides are patient-specific devices that are based on preoperative planning software and assist surgeons in transferring this preoperative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments. The PROPHECY™ patient-specific guides are accompanied by the preoperative report and serve as a template for traditional alignment instrumentation used with Wright Medical's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems.

The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extraarticular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh fractures. ORTHOLOC™ 3Di Locking Screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material. ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, ostectorny, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device. Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

The subject ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is designed to facilitate fracture fixation of the fibula and tibia. The system achieves its intended effect through the use of the various titanium alloy (Type II Anodized) straight, anatomical, and contoured plates and both locking and non-locking screws.

PRO-DENSE™ LoVisc Bone Graft Substitute is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. PRO-DENSE™ LoVisc Bone Graft Substitute resorbs and is replaced with bone during process. PRO-DENSE™ LoVisc Bone Graft Substitute cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during process. PRO-DENSE™ LoVisc Bone Graft Substitute is provided sterile for single use only.

PRO-DENSE™ LoVisc Bone Graft Substitute is a composite of calcium sulfate and calcium phosphate. The formulation consists of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INBONE™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.

The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INBONE Total Ankle System and INFINITY Total Ankle System are additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.

The PROSTEP™ TBI™ (Tailor's Bunion Implant) system is indicated for the fixation of 5th metatarsal osteotomies made in the correction of Tailor's Bunion.

The PROSTEP™ TBI™ (Tailors Bunion Implant) System is intended for use in bone reconstruction and osteotomy of the fifth metatarsal. The implants are provided sterile and consist of one MIS Bunion implant and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.