Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

052

Date of Entry 07/15/2019 

FR Recognition Number

8-497

Standard

ISO 5834-5 Second edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method

Scope/Abstract

This 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.

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
§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

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.