Orthotic News
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Excite Medical participates in successful trade mission to Ecuador
Excite Medical, the maker of the revolutionary DRX9000™ spinal decompression machine, participated in a successful trade mission to Quito, Ecuador April 4–7, facilitated by Enterprise Florida. “It was an honor to participate in this trade mission to Ecuador, meet leaders and executives, and help spread the word about non-surgical, drug-free treatments for low back pain,” ...
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FDA Awards Breakthrough Device Designation to the ReWalk ReBoot Soft Exo-Suit
ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading global manufacturer of robotic medical devices for individuals with lower limb disabilities, today announced its ReBoot device has been granted designation as a Breakthrough Device by the Food and Drug Administration (FDA). The ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory ...
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Villa Beretta Rehabilitation Center - BioXtreme Post Marketing Evaluation Site
Villa Beretta Rehabilitation Center and BioXtreme are proud to announce that they have agreed to conduct a joint evaluation project in the hospital’s facility in Costa-Masnaga, Italy. BioXtreme has developed a ground-breaking robotic device for motor-learning, based on innovative error enhancement technology for upper limb rehabilitation from stroke and other neurological injuries. Villa ...
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ASTM F1582 - 98(2011) Standard Terminology Relating to Spinal Implants
1. Scope 1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses. 2. Referenced Documents (purchase separately) ASTM Standards E6 Terminology Relating to Methods of Mechanical Testing E1150 Definitions of Terms Relating to Fatigue Index Terms 0 Spinal implants; Terminology--medical/surgical systems/applications ICS ...
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ASTM F2267 - 04(2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since ...
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ASTM F2346 - 05(2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
Artificial intervertebral discs are orthopaedic implants that replace degenerated natural intervertebral discs. Their function is to support the anterior column of the spine while allowing motion at the operated level. These test methods outline materials and methods for the characterization of the mechanical performance of different artificial intervertebral discs ...
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ASTM F2180 - 02(2011)e1 Standard Specification for Metallic Implantable Strands and Cables
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling ...
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ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications. Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or ...
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ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone manufacturers supplying material ...
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ASTM F136 - 11 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the ...
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ASTM F755 - 99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
This specification covers the raw material and final product requirements, and the associated test methods for the selection of porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded ...
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ASTM F1378 - 12 Standard Specification for Shoulder Prostheses
This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. The prostheses may be constrained, partially constrained, or unconstrained. Modular prostheses are included in this ...
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ASTM F620 - 11 standard specification for titanium alloy forgings for surgical implants in the alpha plus beta condition
This specification covers alpha plus beta titanium alloy forgings for use in surgical implants such as orthopaedic medical devices. The products should be forged by hammering, pressing, extruding, or upsetting bars or wires and should be free of ...
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ASTM F629 - 11 standard practice for radiography of cast metallic surgical implants
The requirements in this practice are intended to control the quality of the radiographic image of cast metallic surgical implants and related weldments. 1. Scope 1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments. 1.2 The values ...
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ASTM F1295 - 11 standard specification for wrought titanium-6aluminum-7niobium alloy for surgical implant applications (UNS R56700)
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional ...
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ASTM F2180 - 02(2011) standard specification for metallic implantable strands and cables
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 ...
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ASTM F2428 - 04(2011) standard guide for selection and use for pelvic ring circumferential compression stabilization devices (PRCCSD)
The intent of this guide is to identify the general performance and good practice standards that a pelvic ring circumferential compression stabilization device (PRCCSD) should possess. Currently, a number of base platforms such as full-body spinal immobilization devices (long boards) are used to immobilize patients during transport and before definitive treatment. These platforms limit gross ...
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ChildFund partners with physicians for peace in Haiti
One year after the 7.0 earthquake devastated Haiti, ChildFund International continues its work in Haiti with Physicians for Peace. ChildFund has awarded Physicians for Peace a $500,000 grant to support the organization's work in Haiti, providing custom-fitted prosthetics, medical equipment, a summer camp for children with disabilities or who have parents with disabilities and many additional ...
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