Prosthesis, Knee, Femorotibial, Non-constrained, Metal/composite Cemented

Device Code: 4558

Product Code(s): KTX

Device Classification Information

Device Type ID	4558
Device Name	Prosthesis, Knee, Femorotibial, Non-constrained, Metal/composite Cemented
Regulation Description	Knee Joint Femorotibial Metal/composite Non-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	888.3490 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	KTX
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

8-365 ASTM D1505-10
Standard Test Method For Density Of Plastics By The Density-Gradient Technique
8-368 ASTM F2625-10 (Reapproved 2016)
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
8-378 ASTM D792-13
Standard Test Methods For Density And Specific Gravity (Relative Density) Of Plastics By Displacement
8-379 ISO 11542-2 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)]
8-403 ASTM D638-14
Standard Test Method For Tensile Properties Of Plastics
8-404 ASTM E647-15
Standard Test Method For Measurement Of Fatigue Crack Growth Rates
8-423 ASTM F2565-13
Standard Guide For Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms For Surgical Implant Applications
8-424 ASTM F2695-12
Standard Specification For Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) And Fabricated Forms For Surgical Implant Applications
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
11-234 ASTM F732-00 (Reapproved 2011)
Standard Test Method For Wear Testing Of Polymeric Materials Used In Total Joint Prostheses
11-258 ASTM F2083-12
Standard Specification For Total Knee Prosthesis
11-275 ASTM F2381-10
Standard Test Method For Evaluating Trans-Vinylene Yield In Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended For Surgical Implants By Infrared Spectroscopy
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
11-308 ASTM F3161-16
Standard Test Method For Finite Element Analysis (FEA) Of Metallic Orthopaedic Total Knee Femoral Components Under Closing Conditions.
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
11-342 ASTM F732-17
Standard Test Method For Wear Testing Of Polymeric Materials Used In Total Joint Prostheses

Total Product Life Cycle

Device Type ID	4558
Device	Prosthesis, Knee, Femorotibial, Non-constrained, Metal/composite Cemented
Product Code	KTX
FDA Device Classification	Class 2 Medical Device
Regulation Description	Knee Joint Femorotibial Metal/composite Non-constrained Cemented Prosthesis.
CFR Regulation Number	888.3490 [🔎]

TPLC Last Update: 2019-04-02 20:51:38