FDA 510(k) Applications for Medical Device Product Code "OQG"
(Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K122783 | AESCULAP IMPLANT SYSTEM, INC. | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | 10/30/2013 |
| K130652 | CONSENSUS ORTHOPEDICS, INC. | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | 12/17/2013 |
| K172651 | Encore Medical, L.P. | FMP Extended Liners | 12/13/2017 |
| K140130 | ENCORE MEDICAL, L.P. | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED | 11/06/2014 |
| K130365 | ENCORE MEDICAL, L.P. | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | 09/23/2013 |
| K203472 | Kyocera Medical Technologies, Inc. | KMTI Hip Replacement System | 04/02/2021 |
| K201660 | Kyocera Medical Technologies, Inc. | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | 07/16/2020 |
| K200328 | Kyocera Medical Technologies, Inc. | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | 03/11/2020 |
| K202705 | MicroPort Orthopedics Inc. | Prime and DYNASTY« Additive Manufacturing Shells | 08/20/2021 |
| K140701 | NOVOSOURCE INC | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG | 06/27/2014 |
| K122158 | PIPELINE BIOMEDICAL PRODUCTS, LLC | PBP TOTAL HIP SYSTEM | 12/11/2012 |
| K112802 | PIPELINE ORTHOPEDICS | PIPELINE TOTAL HIP SYSTEM | 03/09/2012 |
| K171543 | Renovis Surgical Technologies | Renovis Surgical Hip Replacement System | 11/16/2017 |
| K143647 | Renovis Surgical Technologies, Inc. | Renovis Surgical Hip Replacement System | 05/11/2015 |
| K112897 | RENOVIS SURGICAL TECHNOLOGIES, LLC | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS | 06/13/2012 |
| K122773 | STELKAST COMPANY | CROSS-OVER ACETABULAR SHELL & LINER | 10/09/2012 |
| K094035 | STELKAST COMPANY | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM | 03/24/2011 |
| K141972 | TOTAL JOINT ORTHOPEDICS, INC. | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | 10/09/2014 |
| K173104 | Total Joint Orthopedics, Inc. | Klassic HD« Hooded Acetabular Insert with E-Link« Poly, Klassic HD« Low Profile Acetabular Insert with E-Link« Poly | 10/27/2017 |
| K120370 | ZIMMER, INC. | VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS | 06/04/2012 |
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