Search Results
Found 1181 results
510(k) Data Aggregation
(31 days)
Ask a specific question about this device
(131 days)
Ask a specific question about this device
(102 days)
Ask a specific question about this device
(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"
N/A
Ask a specific question about this device
(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.
N/A
Ask a specific question about this device
(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:
-
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
-
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
N/A
Ask a specific question about this device
(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.
N/A
Ask a specific question about this device
(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.
N/A
Ask a specific question about this device
(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.
N/A
Ask a specific question about this device
(54 days)
The ToeJack MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.
The ToeJack MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and locking 3.0mm diameter titanium screws that provide fixation for the first metatarsal in the correction of a bunion. Specifically, the plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the proximal shaft with 2 screw fixation and extramedullary medial insertion of the 2 distal screws. Further, the device is provided with a screw targeting insertion guide.
N/A
Ask a specific question about this device
Page 1 of 119