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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)

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The Excelsior External Fixation System is indicated for adult and pediatric (greater than 2 through 21 years of age) patients for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Excelsior External Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Excelsior Translation Device is not intended for weight bearing applications. Patients must remain non weight bearing on the Excelsior External Fixation frame when the Excelsior Translation Device is used for transport applications.

The Blue Ocean Global Excelsior System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, telescoping struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. Special wrenches and accessories are included for the proper assembly of the components. The system is manufactured from stainless steel, aluminum, and titanium.

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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.

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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.

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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.

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The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are intended for single use only. The Tyber Medical Trauma Screws are not for spinal use.

This traditional 510(k) submission adds configurations of the previously cleared Tyber Medical Trauma Screws under K192975 and K153575. The Tyber Medical Trauma Screw is designed to allow compression and fixation between two adjacent bone segments. The screw is available with thread diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, and 9.0mm. The screw is configured to have either full thread, long thread, or short thread. The multiple thread lengths come in various options which can assist to ensure fit for various bone sizes. General trauma screws are intended for compression and fixation of bone.

This Submission also references Washers and Trays. The Trays are specific to the Tyber Medical Trauma Screws.

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The Syndesmosis TightRope PRO is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Syndesmosis TightRope PRO is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The Syndesmosis TightRope PRO devices are comprised of various configurations of two metal buttons (round and oblong) preloaded onto an inserter with #5 suture (implanted) and #2-0 FiberWire suture (passing suture), a one-hole washer or two-hole buttress plate. The proposed Syndesmosis TightRope PRO devices will utilize the existing #5 suture (implanted) and two-hole buttress plate previously cleared within K201522 – Arthrex Syndesmosis TightRope XP Buttress Plate Implant System. The proposed Syndesmosis TightRope PRO devices may be packaged as standalone devices or together with ancillary instruments to aid in insertion.

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The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult patients for the treatment and fixation of:

• Open and Closed Fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures of the distal radius
• Bone transport

The Hoffmann LRF System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Lisfranc dislocations

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. The system components are manufactured from aluminum, carbon fiber, stainless steel, and various polymers. The system also encompasses a web application and mobile application.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

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The Monkey Rings™ External Fixation System is intended to be used in adults and pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).

The Monkey Rings External Ring Fixation System is intended to treat the following patient indications in pediatric patients and adults for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g., orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Monkey Rings External Ring Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Monkey Rings External Ring Fixation System is a modular, ring-based external fixation system intended for the treatment and fixation of a variety of orthopedic conditions in pediatric and adult patients. The system is designed to stabilize bone segments during fracture management, deformity correction, or limb lengthening procedures. It consists of multiple components, including rings, connecting rods, struts, bolts, fasteners, clamps, plates, pins, and Kirschner wires (K-wires), which can be assembled in various configurations to provide either static fixation or gradual adjustment of bone position. The modular design allows surgeons to tailor the construct to meet specific anatomical and clinical needs.

The subject components included in this submission are the Universal Joint Struts and updated sterilization parameters for the system. The Universal Joint Strut is a newly introduced component designed to allow precise modification of strut length and controlled repositioning of the fixation rings over time. Its universal joint mechanism provides enhanced angular flexibility, enabling improved intraoperative adjustability and postoperative frame modification while maintaining structural stability and fixation integrity. All other components of the Monkey Rings External Ring Fixation System, including rings, connecting rods, and associated fixation hardware, were previously cleared and remain unchanged in design and function.

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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"

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