ASTM-F2083 2011

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F2083-11 Standard Specification for Total Knee Prosthesis

Published By	Publication Date	Number of Pages
ASTM	2011	9

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

ASTM F2083-11

Historical Standard: Standard Specification for Total Knee Prosthesis

ASTM F2083

Scope

1.1 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. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F1672.

1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for, or capable of, being used with cement, regardless of whether the same components can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.

1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself define a device that will provide adequate clinical performance.

1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

Keywords

arthroplasty; contact area; contact pressure; fatigue; knee; knee constraint; knee prosthesis; knee wear; particles; surface roughness; total knee replacement; TKR; UHMWPE; Knee replacement prosthesis–specifications; Medical materials/applications–specifications; Orthopaedic medical devices–specifications

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2083-11

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology Classification Material
3	Performance Requirements
4	Dimensions Finishing and Marking Packaging and Package Marking Keywords
5	X1. GLOSSARY (Refer to X1.1 anteroposterior distance (APD), n X1.2 distal condylar height (DCH), n X1.3 effective bone resection distance, n X1.4 femoral stem length (FSL), n X1.5 intercondylar dimension (ICD), n X1.6 intercondylar notch width (INW), n X1.7 mediolateral distance width (MLW), n FIG. 1
6	X1.8 overall femoral component length (FCL), n X1.9 patellar flange angle (PFA), n X1.10 patellar flange height (PFH), n X1.11 patellar groove angle (PGA), n X1.12 posterior condylar angle (PCA), n X1.13 posterior condylar height (PCH), n X1.14 posterior condylar thickness (PCT), n X1.15 resected anteroposterior distance (RAPD), n X1.16 stem anteroposterior angle (SAPA), n X1.17 stem mediolateral angle (SMLA), n X1.18 stem diameter (SD), n X1.19 stem mediolateral dimension (SMLD), n X1.20 stem anterioposterior dimension (SAPD), n X1.21 tibial component thickness (TCT), n X1.22 tibial articular surface thickness (TAT), n X1.23 tibial tray thickness (TTT), n X1.24 tibial stem length (TSL), n X1.25 tibial intercondylar spine width (TIW), n X1.26 tibial intercondylar spine height (TIH), n X2. RATIONALE X2.1 X2.2 X2.3
7	X2.4 X2.5 X2.6 X2.7 X2.8 X2.9 X2.10 X2.11 X2.12 X2.13
8	REFERENCES

Additional information

Standard Title	F2083-11 Standard Specification for Total Knee Prosthesis
Published Code	ASTM
Publication Date	2011
Pages Count	9
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F2083 2011

ASTM F2083-11

Historical Standard: Standard Specification for Total Knee Prosthesis

ASTM F2083

PDF Catalog

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