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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 11-381
Standard
ASTM F2582-20
Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
Scope/Abstract
1.1 This test method covers a procedure to simulate dynamic impingement between femoral and acetabular components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined in 8.2); and, if necessary, quantitative assessment of changes in modular component attachment strength.

1.2 This test method can be used to evaluate impingement between femoral components and the following: single-piece, modular, semi-constrained, bipolar, constrained, or dual mobility acetabular components, manufactured from polymeric, metallic, or ceramic materials.
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.
Transition Period
FDA recognition of ASTM F2582-14 [Rec# 11-293] will be superseded by recognition of ASTM F2582-20 [Rec# 11-381]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-293] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 11-293] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation Class 3 OVO
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented Class 3 LPF
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing Class 3 NXT
Regulation Number Device Name Device Class Product Code
§888.3300 Prosthesis, Hip, Constrained, Metal Class 3 KXD
Regulation Number Device Name Device Class Product Code
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Class 2 PBI
Regulation Number Device Name Device Class Product Code
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
Regulation Number Device Name Device Class Product Code
§888.3350 Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class 2 OQH
§888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 JDI
Regulation Number Device Name Device Class Product Code
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
Regulation Number Device Name Device Class Product Code
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
Regulation Number Device Name Device Class Product Code
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer Class 3 KXB
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented Class 3 OCG
Regulation Number Device Name Device Class Product Code
§888.3340 Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 KMC
Regulation Number Device Name Device Class Product Code
§888.3360 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 LWJ
Regulation Number Device Name Device Class Product Code
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
Regulation Number Device Name Device Class Product Code
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
FDA Technical Contact
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
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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