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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 11-282
Standard
ASTM F1223-14 Standard Test Method for Determination of Total Knee Replacement Constraint
Scope/Abstract
1.1 This test method covers the establishment of a database of total knee replacement (TKR) motion characteristics with the intent of developing guidelines for the assignment of constraint criteria to TKR designs. (See the Rationale in Appendix X1.)

1.2 This test method covers the means by which a TKR constraint may be quantified according to motion delineated by the inherent articular design as determined under specific loading conditions in an in vitro environment.

1.3 Tests deemed applicable to the constraint determination are antero-posterior draw, medio-lateral shear, rotary laxity, valgus-varus rotation, and distraction, as applicable. Also covered is the identification of geometrical parameters of the contacting surfaces which would influence this motion and the means of reporting the test results. (See Practices E4.)

1.4 This test method is not a wear test.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
No CFR Citation for the following procodes
Regulation Number Device Name Device Class Product Code
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
Regulation Number Device Name Device Class Product Code
§888.3480 Metal Cemented Constrained Femorotibial Knee Prosthesis Class 3 KRN
Regulation Number Device Name Device Class Product Code
§888.3510 Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class 2 KRO
Regulation Number Device Name Device Class Product Code
§888.3520 Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class 2 HSX
Regulation Number Device Name Device Class Product Code
§888.3530 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class 2 HRY
Regulation Number Device Name Device Class Product Code
§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
Regulation Number Device Name Device Class Product Code
§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/Metal/Polymer Class 2 JWH
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
Regulation Number Device Name Device Class Product Code
§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
Regulation Number Device Name Device Class Product Code
§888.3500 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite Class 2 KYK
Relevant FDA Guidance and/or Supportive Publications*
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
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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