ASTM F2083-12

Standard Organization:

ASTM F2083-12
Standard Specification for Total Knee Prosthesis

Recognition Date2014-01-30
Recognition List034
Recognition Number11-258
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Orthopedic
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This specification is intended to cover all the widely used generic types of knee replacement prostheses used to provide functioning articulation. This includes total knee replacement (TKR) and unicondylar knee replacement (UKR) prostheses of both fixed and mobile bearing varieties, and for primary or revision surgeries. 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.

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; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
§888.3560 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Class 2 MBV
§888.3560 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Class 2 OIY
§888.3560 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class 2 JWH
§888.3550 Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal Class 3 KRP
§888.3550 Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer Class 2 KRQ
§888.3530 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class 2 HRY
§888.3520 Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class 2 HSX
§888.3510 Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class 2 KRO
§888.3500 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite Class 2 KYK
§888.3490 Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented Class 2 KTX
§888.3490 Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented Class 2 KMB
§888.3480 Metal Cemented Constrained Femorotibial Knee Prosthesis Class 3 KRN
Unclassified Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer Class 3 LXY
Unclassified Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 3 MBD
Unclassified Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing Class 3 NJL

FDA Guidance:

Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, January 16, 2003

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