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OQG — Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class II

FDA Device Classification

Classification Details

Product Code
OQG
Device Class
Class II
Regulation Number
888.3358
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K202705microport orthopedicsPrime and DYNASTY® Additive Manufacturing ShellsAugust 20, 2021
K203472kyocera medical technologiesKMTI Hip Replacement SystemApril 2, 2021
K201660kyocera medical technologiesKMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular ShelJuly 16, 2020
K200328kyocera medical technologiesTesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular CMarch 11, 2020
K172651encore medical, l.pFMP Extended LinersDecember 13, 2017
K171543renovis surgical technologiesRenovis Surgical Hip Replacement SystemNovember 16, 2017
K173104total joint orthopedicsKlassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile October 27, 2017
K143647renovis surgical technologiesRenovis Surgical Hip Replacement SystemMay 11, 2015
K140130encore medical, l.pX-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HNovember 6, 2014
K141972total joint orthopedicsKLASSIC HD ACETABULAR INSERT WITH E-LINK POLYOctober 9, 2014
K140701novosourceNOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUGJune 27, 2014
K130652consensus orthopedicsVITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERTDecember 17, 2013
K122783aesculap implant systemPLASMAFIT ACETABULAR CUP AND VITELENE INSERTOctober 30, 2013
K130365encore medical, l.pX-ALT HIGHLY CROSS LINKED VE ACETABULAR LINERSeptember 23, 2013
K122158pipeline biomedical productsPBP TOTAL HIP SYSTEMDecember 11, 2012
K122773stelkastCROSS-OVER ACETABULAR SHELL & LINEROctober 9, 2012
K112897renovis surgical technologiesRENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISJune 13, 2012
K120370zimmerVIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERSJune 4, 2012
K112802pipeline orthopedicsPIPELINE TOTAL HIP SYSTEMMarch 9, 2012
K094035stelkastEXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMMarch 24, 2011