Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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8-497
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Standard | |
ISO 5834-5 Second edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method |
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Scope/AbstractThis document specifies the test method for assessing the morphology of UHMWPE moulded forms, which are described in ISO 5834-2. It is not applicable to UHMWPE powder forms, which are described in ISO 5834-1.
NOTE Performance requirements for this test method have not been established. |
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3810 |
Prosthesis, Wrist, Hemi-, Ulnar |
Class 2 |
KXE |
§888.3800 |
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained |
Class 2 |
JWI |
§888.3800 |
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
Class 2 |
JWJ |
§888.3800 |
Prosthesis, Wrist, Semi-Constrained |
Class 2 |
KWM |
§888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
MBF |
§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented |
Class 2 |
PAO |
§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
Class 2 |
KWS |
§888.3660 |
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
Class 2 |
PKC |
§888.3660 |
Shoulder Prosthesis, Reverse Configuration |
Class 2 |
PHX |
§888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
Class 2 |
KWT |
§888.3560 |
Knee Arthroplasty Implantation System |
Class 2 |
OOG |
§888.3560 |
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Class 2 |
NPJ |
§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 |
§888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
KRR |
§888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
Class 2 |
NJD |
§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 |
§888.3520 |
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 |
§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Class 2 |
KWY |
§888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
Class 2 |
MBL |
§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 |
§888.3350 |
Acetabular Cup Orientation System |
Class 2 |
PLW |
§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 |
§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal |
Class 2 |
KMC |
§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 |
§888.3150 |
Prosthesis, Elbow, Constrained, Cemented |
Class 2 |
JDC |
§888.3110 |
Ankle Arthroplasty Implantation System |
Class 2 |
OYK |
§888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSN |
§888.3040 |
Accessory, System, External Fixator, Containing Antimicrobial Agent |
Class 2 |
NJA |
§888.3040 |
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component |
Class 2 |
MRY |
§888.3040 |
Component, Traction, Invasive |
Class 2 |
JEC |
§888.3040 |
Fastener, Fixation, Nondegradable, Soft Tissue |
Class 2 |
MBI |
§888.3040 |
Laparoscopic Bone Anchor Urethropexy Instrument Kit |
Class 2 |
NWN |
§888.3040 |
Pin, Fixation, Resorbable, Hard Tissue |
Class 2 |
OVZ |
§888.3040 |
Pin, Fixation, Smooth |
Class 2 |
HTY |
§888.3040 |
Pin, Fixation, Smooth, Metallic |
Class 2 |
NDL |
§888.3040 |
Pin, Fixation, Threaded |
Class 2 |
JDW |
§888.3040 |
Pin, Fixation, Threaded, Metallic |
Class 2 |
NDM |
§888.3040 |
Prosthesis, Subtalar, Plug, Polymer |
Class 2 |
MJW |
§888.3040 |
Sacroiliac Joint Fixation |
Class 2 |
OUR |
§888.3040 |
Screw, Fixation, Bone |
Class 2 |
HWC |
§888.3040 |
Screw, Fixation, Bone, Non-Spinal, Metallic |
Class 2 |
NDJ |
§888.3040 |
System, External Fixator (With Metallic Invasive Components) |
Class 2 |
NDK |
§888.3040 |
Transtibial Anterior Cruciate Ligament Kit |
Class 2 |
PPQ |
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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