surgical implant News
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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 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 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 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 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 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 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 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 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 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 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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FDA approves first artificial iris
The U.S. Food and Drug Administration has announced its approval of the first stand-alone prosthetic iris in the United States that could help patients with certain types of eye damage see clearly and improve their appearance. The surgically implanted device, called the CustomFlex Artificial Iris, is meant to treat adults and children whose iris — the part of the eye that is colored around ...
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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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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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ASTM F1541 - 02(2011) standard specification and test methods for external skeletal fixation devices
A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed. 1. Scope 1.1 This specification provides a characterization of the design and mechanical function of ...
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Centric Medical Announces Commercial Launch of MTP Plating 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 commercial launch of its MTP Plating System. This System is comprised of various plates, screws and other fixation components intended to stabilize bone segments for indications within the foot and ankle. ...
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Centric Medical Announces First Quarter Participation at Industry Meetings To Showcase Its Foot & Ankle Portfolio
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 that it will be participating in the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting which will be held March 6-10 in New Orleans, Louisiana, as well as the 76th Annual 2018 American College of Foot ...
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