Prosthesis, Knee, Patello/femorotibial, Constrained, Cemented, Polymer/metal/polymer

Device Code: 4553

Product Code(s): KRQ

Device Classification Information

Device Type ID	4553
Device Name	Prosthesis, Knee, Patello/femorotibial, Constrained, Cemented, Polymer/metal/polymer
Regulation Description	Knee Joint Patellofemorotibial Polymer/metal/metal Constrained Cemented Prosthesis.
Regulation Medical Specialty	Orthopedic
Review Panel	Orthopedic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type	510(k)
CFR Regulation Number	888.3550 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	KRQ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

11-191 ISO 14879-1 First Edition 2000-06-01
Implants For Surgery - Total Knee-joint Prostheses - Part 1: Determination Of Endurance Properties Of Knee Tibial Trays
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice For Permanent Marking Of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice For Care And Handling Of Orthopedic Implants And Instruments
11-222 ISO 14243-1 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
11-232 ISO 7207-1 Third Edition 2007-02-01
Implants For Surgery - Components For Partial And Total Knee Joint Prostheses - Part 1: Classification, Definitions And Designation Of Dimensions
11-253 ASTM F1800-12
Standard Test Method For Cyclic Fatigue Testing Of Metal Tibial Tray Components Of Total Knee Joint Replacements
11-258 ASTM F2083-12
Standard Specification For Total Knee Prosthesis
11-281 ASTM F1672-14
Standard Specification For Resurfacing Patellar Prosthesis
11-282 ASTM F1223-14
Standard Test Method For Determination Of Total Knee Replacement Constraint
11-292 ISO 14243-3 Second Edition 2014-11-01
Implants For Surgery - Wear Of Total Knee-joint Prostheses - Part 3: Loading And Displacement Parameters For Wear-testing Machines With Displacement Control And Corresponding Environmental Conditions For Test
11-306 ASTM F1814-15
Standard Guide For Evaluating Modular Hip And Knee Joint Components
11-311 ISO 14243-2 Third Edition 2016-09-01
Implants For Surgery - Wear Of Total Knee-joint Prostheses - Part 2: Methods Of Measurement
11-313 ISO 7207-2 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 [Including AMENDMENT 1 (2016)]
11-318 ASTM F3141-15
Standard Guide For Total Knee Replacement Loading Profiles
11-335 ASTM F3141-17a
Standard Guide For Total Knee Replacement Loading Profiles

Total Product Life Cycle

Device Type ID	4553
Device	Prosthesis, Knee, Patello/femorotibial, Constrained, Cemented, Polymer/metal/polymer
Product Code	KRQ
FDA Device Classification	Class 2 Medical Device
Regulation Description	Knee Joint Patellofemorotibial Polymer/metal/metal Constrained Cemented Prosthesis.
CFR Regulation Number	888.3550 [🔎]

TPLC Last Update: 2019-04-02 20:51:33