Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-501
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Standard | |
ISO 5834-1 Fourth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form |
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Scope/AbstractThis document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
It is not applicable to finished products. |
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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 |
§888.3040 |
Pin, Fixation, Smooth
|
Class 2
|
HTY
|
§888.3040 |
Screw, Fixation, Bone
|
Class 2
|
HWC
|
§888.3040 |
Pin, Fixation, Threaded
|
Class 2
|
JDW
|
§888.3040 |
Component, Traction, Invasive
|
Class 2
|
JEC
|
§888.3040 |
Fastener, Fixation, Nondegradable, Soft Tissue
|
Class 2
|
MBI
|
§888.3040 |
Prosthesis, Subtalar, Plug, Polymer
|
Class 2
|
MJW
|
§888.3040 |
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component
|
Class 2
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MRY
|
§888.3040 |
Screw, Fixation, Bone, Non-Spinal, Metallic
|
Class 2
|
NDJ
|
§888.3040 |
System, External Fixator (With Metallic Invasive Components)
|
Class 2
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NDK
|
§888.3040 |
Pin, Fixation, Smooth, Metallic
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Class 2
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NDL
|
§888.3040 |
Pin, Fixation, Threaded, Metallic
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Class 2
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NDM
|
§888.3040 |
Accessory, System, External Fixator, Containing Antimicrobial Agent
|
Class 2
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NJA
|
§888.3040 |
Laparoscopic Bone Anchor Urethropexy Instrument Kit
|
Class 2
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NWN
|
§888.3040 |
Sacroiliac Joint Fixation
|
Class 2
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OUR
|
§888.3040 |
Pin, Fixation, Resorbable, Hard Tissue
|
Class 2
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OVZ
|
§888.3040 |
Transtibial Anterior Cruciate Ligament Kit
|
Class 2
|
PPQ
|
§888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
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HSN
|
§888.3110 |
Ankle Arthroplasty Implantation System
|
Class 2
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OYK
|
§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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Class 2
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KWZ
|
§888.3310 |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
|
Class 2
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PBI
|
§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal
|
Class 2
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KMC
|
§888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
Class 2
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JDI
|
§888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
|
Class 2
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OQH
|
§888.3350 |
Acetabular Cup Orientation System
|
Class 2
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PLW
|
§888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
Class 2
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LZO
|
§888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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Class 2
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MAY
|
§888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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Class 2
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MEH
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§888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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Class 2
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OQI
|
§888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
|
Class 2
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MBL
|
§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
Class 2
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KWY
|
§888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
|
Class 2
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KMB
|
§888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
|
Class 2
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KTX
|
§888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
|
Class 2
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KYK
|
§888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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Class 2
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KRO
|
§888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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Class 2
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HSX
|
§888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
|
HRY
|
§888.3530 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
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Class 2
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LGE
|
§888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
|
Class 2
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NJD
|
§888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
|
Class 2
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KRR
|
§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
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Class 2
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MBV
|
§888.3560 |
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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Class 2
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NPJ
|
§888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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Class 2
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OIY
|
§888.3560 |
Knee Arthroplasty Implantation System
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Class 2
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OOG
|
§888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
|
Class 2
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KWT
|
§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
Class 2
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KWS
|
§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
|
Class 2
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PAO
|
§888.3660 |
Shoulder Prosthesis, Reverse Configuration
|
Class 2
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PHX
|
§888.3660 |
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
|
Class 2
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PKC
|
§888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
|
Class 2
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MBF
|
§888.3800 |
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
|
Class 2
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JWI
|
§888.3800 |
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
|
Class 2
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JWJ
|
§888.3800 |
Prosthesis, Wrist, Semi-Constrained
|
Class 2
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KWM
|
§888.3810 |
Prosthesis, Wrist, Hemi-, Ulnar
|
Class 2
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KXE
|
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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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