Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic, Cemented

Device Code: 4711

Product Code(s): LPF

Device Classification Information

Device Type ID	4711
Device Name	Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic, Cemented
Review Panel	Orthopedic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type	PMA
FDA Device Classification	Class 3 Medical Device
Product Code	LPF
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

8-194 ISO 6474-1 First Edition 2010-02-15
Implants For Surgery - Ceramic Materials - Part 1: Ceramic Materials Based On High Purity Alumina
8-226 ASTM F603-12 (Reapproved 2016)
Standard Specification For High-Purity Dense Aluminum Oxide For Medical Application
11-183 ASTM F1875-98 (Reapproved 2014)
Standard Practice For Fretting Corrosion Testing Of Modular Implant Interfaces: Hip Femoral Head-bore And Cone Taper Interface
11-238 ASTM F2033-12
Standard Specification For Total Hip Joint Prosthesis And Hip Endoprosthesis Bearing Surfaces Made Of Metallic, Ceramic, And Polymeric Mateirals
11-239 ASTM F2345-03 (Reapproved 2013)
Standard Test Methods For Determination Of Static And Cyclic Fatigue Strength Of Ceramic Modular Femoral Heads
11-250 ISO 14242-3 First Edition 2009-03-15
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
11-267 ASTM F2009-00 (Reapproved 2011)
Standard Test Method For Determining The Axial Disassembly Force Of Taper Connections Of Modular Prostheses
11-277 ISO 7206-6 Second Edition 2013-11-15
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 6: Determination Of Endurance Properties Of Head And Neck Region Of Stemmed Femoral Components
11-279 ASTM F2996-13
Standard Practice For Finite Element Analysis (FEA) Of Non-Modular Metallic Orthopaedic Hip Femoral Stems
11-286 ASTM F2979-14
Guide For Characterization Of Wear From The Articulating Surfaces In Retrieved Metal-on-Metal And Other Hard-on-Hard Hip Prostheses
11-291 ISO 14242-1 Third Edition 2014-10-15
Implants For Surgery -- Wear Of Total Hip-joint Prostheses - Part 1: Loading And Displacement Parameters For Wear-testing Machines And Corresponding Environmental Conditions For Test
11-295 ASTM F2580-13
Standard Practice For Evaluation Of Modular Connection Of Proximally Fixed Femoral Hip Prosthesis
11-299 ASTM F2068-15
Standard Specification For Femoral Prostheses - Metallic Implants
11-306 ASTM F1814-15
Standard Guide For Evaluating Modular Hip And Knee Joint Components
11-312 ISO 7206-4 Third Edition 2010-06-15
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 4: Determination Of Endurance Properties And Performance Of Stemmed Femoral Components [Including AMENDMENT 1 (2016)]
11-314 ISO 14242-2 Second Edition 2016-09-15
Implants For Surgery - Wear Of Total Hip-joint Prostheses - Part 2: Methods Of Measurement
11-320 ISO 7206-13 First Edition 2016-07-01
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 13: Determination Of Resistance To Torque Of Head Fixation Of Stemmed Femoral Components
11-337 ISO 16087 First Edition 2013-10-01
Implants For Surgery - Roentgen Stereophotogrammetric Analysis For The Assessment Of Migration Of Orthopaedic Implants
11-338 ISO 11491 First Edition 2017-07
Implants For Surgery - Determination Of Impact Resistance Of Ceramic Femoral Heads For Hip Joint Prostheses
11-339 ISO 7206-2 Third Edition 2011-04-01 AMENDMENT 1 2016-09-15
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 2: Articulating Surfaces Made Of Metallic, Ceramic And Plastics Materials [Including AMENDMENT1 (2016) ]
11-340 ASTM F3018-17
Standard Guide For Assessment Of Hard-on-Hard Articulation Total Hip Replacement And Hip Resurfacing Arthroplasty Devices
11-344 ASTM F2580-18
Standard Practice For Evaluation Of Modular Connection Of Proximally Fixed Femoral Hip Prosthesis

Total Product Life Cycle

Device Type ID	4711
Device	Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic, Cemented
Product Code	LPF
FDA Device Classification	Class 3 Medical Device

Device Problems
Fracture	1
Device Dislodged Or Dislocated	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:54:17