OQG · Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Orthopedic · 21 CFR 888.3358 · Class 2
Overview
| Product Code | OQG |
|---|---|
| Device Name | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
Classification Rationale
Class II.
Cleared Devices (20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | Microport Orthopedics, Inc. | Aug 20, 2021 | SESE |
| K203472 | KMTI Hip Replacement System | Kyocera Medical Technologies, Inc. | Apr 2, 2021 | SESE |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | Jul 16, 2020 | SESE |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | Mar 11, 2020 | SESE |
| K172651 | FMP Extended Liners | Encore Medical L.P. | Dec 13, 2017 | SESE |
| K171543 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies | Nov 16, 2017 | SESE |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | Total Joint Orthopedics, Inc. | Oct 27, 2017 | SESE |
| K143647 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies, Inc. | May 11, 2015 | SESE |
| K140130 | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED | Encore Medical L.P. | Nov 6, 2014 | SESE |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | Total Joint Orthopedics, Inc. | Oct 9, 2014 | SESE |
| K140701 | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG | Novosource, Inc. | Jun 27, 2014 | SESE |
| K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | Consensus Orthopedics, Inc. | Dec 17, 2013 | SESE |
| K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | Aesculap Implant System, Inc. | Oct 30, 2013 | SESE |
| K130365 | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | Encore Medical L.P. | Sep 23, 2013 | SESE |
| K122158 | PBP TOTAL HIP SYSTEM | Pipeline Biomedical Products, LLC | Dec 11, 2012 | SESE |
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER | Stelkast Company | Oct 9, 2012 | SESE |
| K112897 | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS | Renovis Surgical Technologies, LLC | Jun 13, 2012 | SESE |
| K120370 | VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS | Zimmer, Inc. | Jun 4, 2012 | SESE |
| K112802 | PIPELINE TOTAL HIP SYSTEM | Pipeline Orthopedics | Mar 9, 2012 | SESE |
| K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM | Stelkast Company | Mar 24, 2011 | SESE |
Top Applicants
- Kyocera Medical Technologies, Inc. — 3 clearances
- Encore Medical L.P. — 3 clearances
- Total Joint Orthopedics, Inc. — 2 clearances
- Stelkast Company — 2 clearances
- Zimmer, Inc. — 1 clearance
