FDA Product Code OQG: Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
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.
Leading manufacturers include Kyocera Medical Technologies, Inc., Encore Medical, L.P. and Total Joint Orthopedics, Inc..
20
Total
20
Cleared
176d
Avg days
2011
Since
FDA 510(k) Cleared Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented Devices (Product Code OQG)
20 devices
Cleared
Aug 20, 2021
Prime and DYNASTY® Additive Manufacturing Shells
Microport Orthopedics, Inc.
Orthopedic
338d
Cleared
Apr 02, 2021
KMTI Hip Replacement System
Kyocera Medical Technologies, Inc.
Orthopedic
128d
Cleared
Jul 16, 2020
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Kyocera Medical Technologies, Inc.
Orthopedic
28d
Cleared
Mar 11, 2020
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Kyocera Medical Technologies, Inc.
Orthopedic
30d
Cleared
Dec 13, 2017
FMP Extended Liners
Encore Medical, L.P.
Orthopedic
99d
Cleared
Nov 16, 2017
Renovis Surgical Hip Replacement System
Renovis Surgical Technologies
Orthopedic
174d
Cleared
Oct 27, 2017
Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
Total Joint Orthopedics, Inc.
Orthopedic
28d
Cleared
May 11, 2015
Renovis Surgical Hip Replacement System
Renovis Surgical Technologies, Inc.
Orthopedic
140d
Cleared
Nov 06, 2014
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
Encore Medical, L.P.
Orthopedic
293d
Cleared
Oct 09, 2014
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
Total Joint Orthopedics, Inc.
Orthopedic
80d
Cleared
Jun 27, 2014
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
Novosource, Inc.
Orthopedic
99d
Cleared
Dec 17, 2013
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
Consensus Orthopedics, Inc.
Orthopedic
280d
Cleared
Oct 30, 2013
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
Aesculap Implant System, Inc.
Orthopedic
414d
Cleared
Sep 23, 2013
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
Encore Medical, L.P.
Orthopedic
222d
Cleared
Dec 11, 2012
PBP TOTAL HIP SYSTEM
Pipeline Biomedical Products, LLC
Orthopedic
144d
Cleared
Oct 09, 2012
CROSS-OVER ACETABULAR SHELL & LINER
Stelkast Company
Orthopedic
29d
Cleared
Jun 13, 2012
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
Renovis Surgical Technologies, LLC
Orthopedic
254d
Cleared
Jun 04, 2012
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
Zimmer, Inc.
Orthopedic
119d
Cleared
Mar 09, 2012
PIPELINE TOTAL HIP SYSTEM
Pipeline Orthopedics
Orthopedic
164d
Cleared
Mar 24, 2011
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
Stelkast Company
Orthopedic
449d