Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
059
|
Date of Entry 12/19/2022
|
FR Recognition Number
|
11-395
|
Standard | |
ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components |
|
Scope/Abstract1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.
1.2 This guide does not attempt to define all test methods associated with modular device evaluation.
1.3 The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads. |
|
Extent of Recognition
|
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FDA recognition of ASTM F1814-15 [Rec# 11-306] will be superseded by recognition of ASTM F1814-22 [Rec# 11-395]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-306] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 11-306] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
N/A |
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation |
Class 3
|
OVO
|
N/A |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3
|
MBD
|
N/A |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
|
NJL
|
N/A |
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
Class 3
|
NRA
|
N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing |
Class 3
|
NXT
|
N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented |
Class 3
|
LPF
|
N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
|
MRA
|
N/A |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer |
Class 3
|
LXY
|
§888.3300 |
Prosthesis, Hip, Constrained, Metal
|
Class 3
|
KXD
|
§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
|
§888.3320 |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
|
Class 3
|
JDL
|
§888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
Class 3
|
KWA
|
§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
|
Class 2
|
KMC
|
§888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
Class 2
|
JDI
|
§888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
|
Class 2
|
OQH
|
§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
|
§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
|
§888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
Class 2
|
LPH
|
§888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
|
Class 2
|
OQG
|
§888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
|
Class 2
|
MBL
|
§888.3360 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
|
Class 2
|
LWJ
|
§888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal
|
Class 2
|
KWL
|
§888.3360 |
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
|
Class 2
|
LZY
|
§888.3360 |
Prosthesis, Upper Femoral
|
Class 2
|
JDD
|
§888.3360 |
Prosthesis, Hip, Femoral Component, Cemented, Metal
|
Class 2
|
JDG
|
§888.3370 |
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
|
Class 3
|
KWB
|
§888.3380 |
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
|
Class 3
|
JDH
|
§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
Class 2
|
KWY
|
§888.3400 |
Prosthesis, Hip, Femoral, Resurfacing
|
Class 2
|
KXA
|
§888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
|
Class 3
|
KXB
|
§888.3410 |
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
|
Class 3
|
OCG
|
§888.3480 |
Metal Cemented Constrained Femorotibial Knee Prosthesis
|
Class 3
|
KRN
|
§888.3480 |
Prosthesis, Knee, Hinged (Metal-Metal)
|
Class 3
|
HRZ
|
§888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
|
Class 2
|
KMB
|
§888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
|
Class 2
|
KTX
|
§888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
|
Class 2
|
KYK
|
§888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
Class 2
|
KRO
|
§888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
Class 2
|
HSX
|
§888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
|
HRY
|
§888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
|
Class 2
|
LGE
|
§888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
|
Class 2
|
NJD
|
§888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
|
KRR
|
§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
|
§888.3560 |
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
Class 2
|
NPJ
|
§888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
Class 2
|
JWH
|
§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
|
§888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
Class 2
|
MBH
|
§888.3570 |
Prosthesis, Knee, Hemi-, Femoral (Uncemented)
|
Class 3
|
KRS
|
§888.3570 |
Prosthesis, Knee, Hemi-, Femoral
|
Class 3
|
HSA
|
§888.3580 |
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
|
Class 2
|
HTG
|
§888.3590 |
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
|
Class 2
|
HSH
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components, issued May 1995.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |
|
|