Knee Replacement System

Recognized Consensus Standards

Product Classification
Device

Prosthesis, knee, patellofemorotibial,

semi-constrained,
cemented, polymer/ metal/ polymer
Regulation Description
polymer/metal/ polymer
constrained cemented prosthesis

Knee joint patellofemorotibial

semi-

Regulation Medical Specialty

Orthopedic

Product Code

JWH

Regulation Number

21 CFR 888.3560

Implanted Device

Yes

Life-Sustain/Support Device -

No

General Standards
STANDARD

TITLE

ASTM D1505-10

Standard Test Method for Density of Plastics by the Density-Gradient

Technique

ASTMF2625-10

Standard Test Method for Measurement of Enthalpy of Fusion, Percent

Crystallinity, and Melting Point of Ultra-High-Molecular Weight
Polyethylene by Means of Differential Scanning Calorimetry

ASTMD792-13

Standard Test Methods for Density and Specific Gravity (Relative

Density) of Plastics by Displacement

ISO11542-2 First
edition 1998-11-15

Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW)

moulding and extrusion materials - Part 2: Preparation of test specimens
and determination of properties [Including: Technical Corrigendum 1
(2007)]

ASTMD638-14

Standard Test Method for Tensile Properties of Plastics

ASTME647-15

Standard Test Method for Measurement of Fatigue Crack Growth Rates

ASTMF2565-13

Standard Guide for Extensively Irradiation-Cross linked Ultra-High

Molecular Weight Polyethylene Fabricated Forms for Surgical Implant
Applications

General Standards

contd.

STANDARD

TITLE

ASTMF2695-12

Standard Specification for Ultra-High Molecular Weight Polyethylene

Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms
for Surgical Implant Applications

ISO14879-1 First
edition 2000-06-01

Implants for surgery - Total knee-joint prostheses - Part 1: Determination

of endurance properties of knee tibial trays

ASTMF983-86
(Reapproved 2013)

Standard Practice for Permanent Marking of Orthopaedic Implant

Components

ASTMF565-04
(Reapproved 2013)

Standard Practice for Care and Handling of Orthopedic Implants and

Instruments

ISO14243-1 Second
edition 2009-11-15

Implants for surgery - Wear of total knee-joint prostheses - Part 1:

Loading and displacement parameters for wear-testing machines with
load control and corresponding environmental conditions for test

ISO14243-2 Second
edition 2009-11-15

Implants for surgery - Wear of total knee-joint prostheses - Part 2:

Methods of measurement

General Standards
STANDARD

contd.
TITLE

ISO7207-2 Second
edition 2011-07-01

Implants for surgery - Components for partial and total knee joint
prostheses - Part 2: Articulating surfaces made of metal, ceramic and
plastics materials

11-232ISO7207-1
Third edition 200702-01

Implants for surgery - Components for partial and total knee joint
prostheses - Part 1: Classification, definitions and designation of
dimensions

ASTMF732-00
(Reapproved 2011)

Standard Test Method for Wear Testing of Polymeric Materials Used in

Total Joint Prostheses

ASTMF1800-12

Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray
Components of Total Knee Joint Replacements

ASTMF2083-12

Standard Specification for Total Knee Prosthesis

ASTMF2381-10

Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated

Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for
Surgical Implants by Infrared Spectroscopy

ASTMF1672-14

Standard Specification for Resurfacing Patellar Prosthesis

General Standards
STANDARD

contd.
TITLE

ASTMF1223-14

Standard Test Method for Determination of Total Knee Replacement

Constraint

ISO14243-3 Second
edition 2014-11-01

Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading

and displacement parameters for orbital bearing type wear testing
machines and corresponding environmental conditions for test

ASTMF1814-15

Standard Guide for Evaluating Modular Hip and Knee Joint Components

ASTMF3161-16

Standard Test Method for Finite Element Analysis (FEA) of Metallic

Orthopaedic Total Knee Femoral Components under Closing Conditions.