implant surgical News
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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 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 F2066 - 11 standard specification for wrought titanium-15 molybdenum alloy for surgical implant applications (UNS R58150)
This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; ...
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ASTM F2091 - 01(2012) Standard Specification for Acetabular Prostheses
This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. Acetabular prostheses included within the scope of this specification are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement ...
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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 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 F1147 - 05(2011) standard test method for tension testing of calcium phosphate and metallic coatings
The tensile test method is recommended for tension testing of calcium phosphate/substrate or porous metal coating/substrate combinations and can provide information on the adhesive or cohesive strength of coatings under (uniaxial) tensile stress. The test method may be useful for comparative evaluation of adhesive or cohesive strengths of a variety of types of coatings. Coatings may be ...
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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 F603 - 12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
1. Scope 1.1 This specification covers the material requirements for high-purity, dense aluminum oxide for load-bearing surgical implant applications. 1.2 This specification does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants and the like). It is intended as a ...
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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 F2083 - 11 Standard Specification for Total Knee Prosthesis
This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110' of flexion to high flexion. Replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of ...
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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 F1044 - 05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
The shear test method is recommended for shear testing of calcium phosphate and metallic/substrate combinations and can provide information on the adhesive or cohesive strength of coatings under a uniaxial shear stress. The test method may be useful for comparative evaluation of adhesive or cohesive strengths of a variety of types of coatings. Information developed using this test method may be ...
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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 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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BioPoly Granted an International Patent for Its Implant Technology
FORT WAYNE, IN – BioPoly LLC has announced that the Company has further expanded its intellectual property portfolio. The Company was granted another international patent for its partial resurfacing implants which protects the innovative implant designs. In addition to patents that cover the design of its implants, several U.S. and international patents have also been granted that address ...
By BioPoly, LLC
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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 F1855 - 00(2011) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. Physical and mechanical properties of medical grade ...
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Centric Medical Announces 510(K) Clearance of the Saturn External Fixation System
Centric Medical, a division of Life Spine®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today That the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors intended to be used as a ...
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Centric Medical Announces First Clinical Cases With Saturn External Fixation System
Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the first clinical cases of SATURN External Fixation System. This System is comprised of various rings, struts, pins, bolts, and other fixation components intended to be used as a means to stabilize bone segments for ...
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