Prosthesis, Upper Femoral

Device Code: 4522

Product Code(s): JDD

Device Classification Information

Device Type ID	4522
Device Name	Prosthesis, Upper Femoral
Regulation Description	Hip Joint Femoral (hemi-hip) Metallic Cemented Or Uncemented 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 Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type	510(k)
CFR Regulation Number	888.3360 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	JDD
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

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
11-238 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
11-267 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
11-295 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)]
11-320 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
11-339 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) ]
11-344 ASTM F2580-18
Standard Practice For Evaluation Of Modular Connection Of Proximally Fixed Femoral Hip Prosthesis

Total Product Life Cycle

Device Type ID	4522
Device	Prosthesis, Upper Femoral
Product Code	JDD
FDA Device Classification	Class 2 Medical Device
Regulation Description	Hip Joint Femoral (hemi-hip) Metallic Cemented Or Uncemented Prosthesis.
CFR Regulation Number	888.3360 [🔎]

Device Problems
Device Dislodged Or Dislocated	2
Appropriate Term/Code Not Available	1
Insufficient Information	1
Total Device Problems	4

TPLC Last Update: 2019-04-02 20:50:58