Search Results

Ask a specific question about this device

Ask a specific question about this device

The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot.

The HKT Anatomical Locking Trauma System is a collection of implantable bone plates and bone screws. The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot. This system consists of Bone Plates, Bone Screws and Washers

N/A

Ask a specific question about this device

The RIB LINK™ Fixation System is indicated for use in the stabilization, fixation, and reconstruction of rib fractures, fusions, osteotomies, resections, including spanning gaps and/or defects, and chest wall deformities including rib hump deformity. These implants are indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation.

The RIB LINK™ Fixation System includes a variety of plates, rods, and screws intended for use in rib fixation and stabilization applications. The implants are available in various sizes and styles and can be assembled in multiple construct configurations to accommodate varying patient anatomy. The constructs can be surgically positioned across the external surface of the ribs. RIB LINK™ implants are manufactured from titanium alloy as specified in ASTM F136.

N/A

Ask a specific question about this device

The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum and other anterior chest wall deformities. It is indicated for use in adult and pediatric (children and adolescents) populations.

The KLS Martin Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum and other anterior chest wall deformities. The implants are provided non-sterile in multiple sizes and are manufactured using traditional manufacturing methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also includes the necessary instruments to facilitate placement of the implants.

The purpose of this submission is as follows:

1. Line extension to include the Pectus Stabilizer

2. Add "MR Conditional" to the device labeling for the Pectus Stabilizer used in conjunction with pectus bar.

3. Expand the Indications for Use to include other anterior chest wall deformities such as Pectus Carinatum and Pectus Arcuatum

N/A

Ask a specific question about this device

The Arthrex Lateral Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.

The Arthrex Medial Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.

The Arthrex Posteromedial Proximal Tibia Plates are intended to be used for internal bone fixation for bone fractures in the tibia.

The Arthrex Variable Angle (VA) Proximal Tibia Plating System is designed for repairing fractures of the tibia. The Arthrex Variable Angle (VA) Proximal Tibia Plating System consists of two Lateral Proximal Tibia Plate types (Standard and High), Posteromedial Proximal Tibia Plates, and Medial Proximal Tibia Plates. The Lateral Proximal Tibia Plates are anatomically contoured, available in left and right configurations, varying plate lengths of 78 mm to 239 mm. The primary difference between the Standard and High Lateral Proximal Tibia Plates is that the High Lateral Proximal Tibia Plate includes four additional 2.7 mm screw holes proximally. The Medial Proximal Tibia Plates are anatomically contoured, available in left and right configuration, and varying plate lengths of 94 mm to 202 mm. The Posteromedial Proximal Tibia Plates are anatomically contoured straight plates offered in varying plate lengths of 87 mm to 137 mm. The Lateral, Posteromedial, and Medial Proximal Tibia Plates within the Arthrex Variable Angle (VA) Proximal Tibia Plating System accept variable angle (VA) and nominal angle locking screws, KreuLock™ screws, cortical screws, as well as cancellous screws. Additionally, the Variable Angle (VA) Proximal Tibia Plates includes K-wire holes for temporary fixation and suture holes to assist in soft tissue management. The proposed plates are manufactured from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136 (ISO 5832-3). The Variable Angle (VA) Proximal Tibia Plates are single use and sold either sterile (Gamma) or non-sterile.

The Arthrex Variable Angle (VA) Proximal Tibia Plating System are compatible with the following Arthrex Screws:

• 2.7 mm Cortical Screw and 2.7 mm VAL Screw (K220937)
• 2.7 mm VAL KreuLock Screws (K242554)
• 3.0 mm Low Profile VA Locking Screw (K213837)
• 3.0 mm KreuLock™ Compression Screw, 3.0 Low Profile VA Locking Screw, Hybrid, 3.0 mm Hybrid KreuLock™ Compression Screw (K242554)
• 3.5 mm Low Profile Screw (K203294, K150456, K143614, K123241, K111253, K103705)
• 3.5 mm Low Profile Locking Screws (K150456, K143614, K111253, K103705)
• 3.5 mm Variable Angle Locking (VAL) Screw, Reinforced, 3.5 mm Variable Angle Locking (VAL) KreuLock™ Screw, Reinforced, 3.5 VAL Screw, 3.5 mm VAL KreuLock Screws (K241592)
• 4.0 mm Low Profile Screw, Cancellous (K150456, K143614, K111253, K103705)

N/A

Ask a specific question about this device

The TriMed Volar Plates are intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies that lend themselves to the principle of plate and screw fixation.

The following fracture configurations may be applicable for treatment using TriMed Volar Plates:

1. Fractures, non-unions or osteotomies of the radius

TriMed Volar Bearing Plates are intended to be used as an aid to the treatment of certain types for fractures, non-unions and osteotomies of the radius. Like every type of orthopaedic implant, these implants cannot be assumed to be uniformly effective without risk. Use of these implants is not a substitute for normal tissue healing. The TriMed Volar Plates are designed to provide additional constraint of movement of a fractured/osteotomized bone and are intended only as an aid to fix the injury in place during the healing process. These plates are made from 316L Stainless Steel per ASTM F138/F139. The new plates will be offered as part of TriMed Wrist Fixation system 3 (received FDA clearance under K222637). They will be made available in 3 sizes (13, 14 &16 holes) for left and right each.

N/A

Ask a specific question about this device

The Anatomic Lapidus Plates and I-Beam Lapidus Plates are intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the foot.

The Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates consists of a series of plates of varying sizes, orientations, and lengths. The proposed plates are available in small, medium, and long, and left and right configurations. The proposed plates (I-Beam Lapidus Plates only) include an internal beam. Each plate provides locking screw fixation. The proposed plates are manufactured from titanium alloy conforming to ASTM F136. The proposed plates are sold sterile (gamma) and are single-use. The proposed Anatomic Lapidus Plates are sold as standalone, whereas the I-Beam Lapidus Plates are packaged as a kit with instrumentation.

N/A

Ask a specific question about this device

The TRILEAP Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.

The TRILEAP™ Plating System is intended for reduction, temporary fixation, fusion and stabilization of bones. The system consists of a family of implantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm non-contoured and anatomic procedure specific plates, cortical screws, variable angle locking screws, and Jones screws available in various sizes. System implants are manufactured from titanium alloy and intended for single use only.

Instruments that may be used with the TRILEAP™ Plating System include Drill Guides, Drill Bits, Cannulated Reamers, Depth Gauges, Bending Pins, Screwdrivers and other instrumentation for general surgery. General instruments are manufactured from stainless steel, aluminum, silicone and plastic. Dedicated system organizational trays are for use in health care facilities for the purpose of containing and protecting medical devices during transportation and storage.

N/A

Ask a specific question about this device

The Pectus Versa System is indicated for the treatment of Pectus Excavatum and other anterior chest wall deformities in adult and pediatric patients (children and adolescents).

The Pectus Versa System consists of implants for treating chest wall deformities in adult and pediatric patients (children and adolescents). When implanted, the bars exert an internal force on the chest wall, enabling the repositioning of the bone structure of the thorax. The system has connecting bars and stabilizers that assist in the assembly of complex systems, stabilizing the system and connecting two or more bars, enabling the surgeon to apply minimally invasive techniques for treating chest wall deformities.

Pectus Versa System implants are manufactured with the following raw materials:

• Titanium Alloy Ti6Al4V according to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications"

N/A

Ask a specific question about this device