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(58 days)
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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(31 days)
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:
- 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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(131 days)
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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(102 days)
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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(260 days)
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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(156 days)
The BRUSIO Trauma Toolbox System is indicated for internal fixation of fractures, osteotomies and nonunions of bones and bone fragments of the appendicular skeleton that are appropriate for the implant size in adult patients. When used in the clavicle, scapula, humerus, olecranon, pelvis, femur, tibia or fibula, the BRUSIO Trauma Toolbox System is intended only for non-load-bearing stabilization and reduction.
The TAMINA, TAMINA Long and TAMINA TF Proximal Humerus System is indicated for
• Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic bone
• Pseudarthroses (non-unions) of the proximal humerus
• Osteotomies of the proximal humerus
The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject devices BRUSIO Trauma Toolbox System and TAMINA 3.5mm Proximal Humerus System are variants of the Bonebridge Osteosynthesis Plating System.
The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139).
All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.
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(91 days)
4.5mm Cortex Screw
The 4.5 mm Cortical Screw is intended for use only in conjunction with compatible plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures and bone fissures where high-strength cortical fixation is required as part of the plate-and-screw construct. The screw provides stable support at the fixation site when used as a component of the APS Osteotomy Fixation System. This screw is not intended for standalone use.
5.0mm Locking Screw
The 5.0 mm Locking Screw is intended for use only with compatible locking plates of the APS Osteotomy Fixation System. It is indicated for fixation of long bone fractures requiring angular stability and reliable screw-plate interface fixation as part of the system construct. The locking mechanism is designed to reduce screw loosening and enhance stability at the fixation site. This screw is not intended for standalone use.
Proximal Medial Tibial Osteotomy Locking Plate
The Proximal Medial Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy procedures, providing fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures on the proximal medial tibia.
Proximal Medial Tibial Osteotomy Locking Plate, Small
The "Proximal Medial Tibial Osteotomy Locking Plate, Small" is designed for high tibial osteotomy. It is indicated for use in deformity correction and osteotomy, providing fixation in general and reconstructive surgeries, as well as bone fusion or osteotomy procedures.
Proximal Lateral Tibial Osteotomy Locking Plate
The Proximal Lateral Tibial Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the proximal lateral tibia, offering fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.
Distal Medial Femoral Osteotomy Locking Plate
The Distal Medial Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal medial femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.
Distal Lateral Femoral Osteotomy Locking Plate
The Distal Lateral Femoral Osteotomy Locking Plate is indicated to be used in deformity correction and osteotomy of the distal lateral femur. It provides fixation in general surgeries, reconstructive surgeries, and bone fusion or osteotomy procedures.
The APS Osteotomy Fixation System is made of titanium and includes fixation plates designed for both the medial and lateral sides of the distal femur and the proximal tibia.
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(255 days)
The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. 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. 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:
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Line extension to include longer pectus bar sizes for both angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm
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Add "MR Conditional" to the device labeling for the angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm used in conjunction with connector bars
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(84 days)
The HyperFlex® Medical HyperFlex® Bunion Correction System is intended for use in reconstruction (correction) of the hallux valgus deformity by holding the reduction of the 1st metatarsal-2nd metatarsal intermetatarsal (IM) angle in adults and pediatric patients aged ≥13 years in which growth plates have fused.
The HyperFlex® Medical HyperFlex Bunion System is an implantable device and accompanying instrumentation used to treat a hallux valgus deformity (bunion). It includes an implant with components that attach to the 1st and 2nd metatarsals which are joined by a flexible central section. The system holds the IM angle between the 1st and 2nd metatarsal without restricting range of motion. The implant will be offered in several sizes to fit the anatomical needs of the patient population.
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(89 days)
The SternaFuse Ti Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall or sternum, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures to promote fusion. The system is intended for use in patients with normal and/or poor bone quality. The device is for prescription use only.
The SternaFuse Ti Fixation System implants are manufactured from titanium alloy (Ti6AL-4V ELI) Per ASTM F136 implant quality titanium plates, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in 3.5mm diameter, and lengths of 10mm, 12mm,14mm,16mm,18mm and 20mm. Multiple plates may be used in one anterior chest wall repair.
All implants are provided non-sterile. The implants should never be reused under any circumstance.
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