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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 8-514
Standard
ISO  5834-2 Fifth edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
Scope/Abstract
This document specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.

This document is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or by blending different forms of polyethylene.
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)*
Regulation Number Device Name Device Class Product Code
§880.6430 Dispenser, Liquid Medication Class 1 KYX
§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 MRY
§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 Pin, Fixation, Smooth, Metallic Class 2 NDL
§888.3040 Pin, Fixation, Threaded, Metallic Class 2 NDM
§888.3040 Accessory, System, External Fixator, Containing Antimicrobial Agent Class 2 NJA
§888.3040 Laparoscopic Bone Anchor Urethropexy Instrument Kit Class 2 NWN
§888.3040 Sacroiliac Joint Fixation Class 2 OUR
§888.3040 Pin, Fixation, Resorbable, Hard Tissue Class 2 OVZ
§888.3040 Transtibial Anterior Cruciate Ligament Kit Class 2 PPQ
§888.3110 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class 2 HSN
§888.3110 Ankle Arthroplasty Implantation System Class 2 OYK
§888.3150 Prosthesis, Elbow, Constrained, Cemented Class 2 JDC
§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
§888.3340 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
§888.3350 Acetabular Cup Orientation System Class 2 PLW
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§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, 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
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
§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
§888.3510 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
§888.3560 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, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class 2 NPJ
§888.3560 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Class 2 OIY
§888.3560 Knee Arthroplasty Implantation System Class 2 OOG
§888.3650 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 KWT
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 KWS
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Class 2 PAO
§888.3660 Shoulder Prosthesis, Reverse Configuration Class 2 PHX
§888.3660 Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class 2 PKC
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§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
§888.3810 Prosthesis, Wrist, Hemi-, Ulnar Class 2 KXE
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.
FDA Technical Contact
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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