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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® Surgical Planning 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® Surgical Planning 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 (e.g. CT scans and X-rays). The Prophecy® Surgical Planning guides are intended for single use only.

The Prophecy® Surgical Planning System is composed of three components: - Prophecy® patient-specific guides - Prophecy® 3D Planner - Prophecy® Preoperative report The Prophecy® Surgical Planning System is compatible with the Inbone®, Infinity®, and Invision® Total Ankle Systems.

The PROstep™ MIS 5mm Chamfer Screw is indicated for fixation of bone reconstruction. Examples include: - Arthrodesis of the first metatarsal cuneiform joint to reposition and stabilize metatarsus primus varus - Calcaneus/cuboid arthrodesis - Talar/navicular arthrodesis

The PROstep™ MIS 5mm Chamfered Screw is designed to facilitate internal fixation for minimally invasive reduction of hallux valgus deformity and subsequent fusion of the first metatarsal cuneiform joint. The subject cannulated screw is made from titanium alloy (ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and features multiple lengths. The subject screw is sterile and provided with both sterile and non-sterile instrumentation.

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.

The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.

The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).

The FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

The FuseForce™ Flex Dynamic Compression System consists of bone staple implants with two-leg and four-leg configurations. The system features low-profile and wide bridges, as well as multiple leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant and instruments for implantation. The implant is designed to provide compression to facilitate bone fusion.

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.