FDA Product Code LZO: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Hip replacement surgery restores mobility and eliminates pain in patients with advanced joint disease. FDA product code LZO covers semi-constrained hip prostheses with metal, ceramic, or polymer bearing surfaces.
These implants replace the femoral head and acetabular socket with engineered bearing couples designed to minimize wear and maximize longevity. Material combinations include metal-on-polyethylene, ceramic-on-ceramic, and ceramic-on-polyethylene.
LZO devices are Class II medical devices, regulated under 21 CFR 888.3353 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Howmedica Osteonics Corp. and Medacta International S.A..
529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
Cleared
Apr 25, 2020
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
Microport Orthopedics, Inc.
Orthopedic
114d
Cleared
Apr 10, 2020
Zimmer Hip Joint Replacement
Zimmer GmbH
Orthopedic
84d
Cleared
Feb 28, 2020
Zimmer M/L Taper Hip Prosthesis
Zimmer, Inc.
Orthopedic
156d
Cleared
Feb 27, 2020
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
Biomet UK, Ltd.
Orthopedic
154d
Cleared
Jan 16, 2020
MobiliT Cup
Corin U.S.A. Limited
Orthopedic
191d
Cleared
Jan 09, 2020
AMIStem-C
Medacta International S.A.
Orthopedic
30d
Cleared
Jan 06, 2020
Quadra-P
Medacta International S.A.
Orthopedic
96d
Cleared
Dec 26, 2019
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
Zimmer GmbH
Orthopedic
55d
Cleared
Dec 21, 2019
Acetabular Bone Screws (for MobileLink Acetabular Cup System)
Waldemar Link GmbH & Co. KG
Orthopedic
95d
Cleared
Dec 18, 2019
Avenir Complete Hip System, Size 0 Coxa Vara
Zimmer, Inc.
Orthopedic
127d
Cleared
Dec 06, 2019
Avenir Muller Stem, Avenir Cemented Hip Stem
Zimmer GmbH
Orthopedic
37d
Cleared
Nov 26, 2019
DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics, Inc.
Orthopedic
39d
Cleared
Nov 22, 2019
AMIStem-P Short Neck
Medacta International S.A.
Orthopedic
108d
Cleared
Nov 01, 2019
DePuy Corail AMT Hip Prosthesis
Depuy(Ireland)
Orthopedic
260d
Cleared
Oct 22, 2019
Exactech Alteon Modular Dual Mobility (MDM) System
Exactech, Inc.
Orthopedic
200d
Cleared
Oct 07, 2019
PROFEMUR TL2 Stems
Microport Orthopedics, Inc.
Orthopedic
110d
Cleared
Oct 01, 2019
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
Zimmer GmbH
Orthopedic
27d
Cleared
Sep 27, 2019
MiniMAX
Medacta International S.A.
Orthopedic
29d
Cleared
Aug 28, 2019
Signature Ceramic Femoral Head
Signature Orthopaedics Pty, Ltd.
Orthopedic
163d
Cleared
Aug 28, 2019
BIOLOX CONTOURA Ceramic Femoral Head
Total Joint Othopedics, Inc.
Orthopedic
96d
Cleared
Aug 23, 2019
Libertas – Taper Uncemented Femoral Stem
Maxx Orthopedics, Inc.
Orthopedic
238d
Cleared
Aug 08, 2019
Conformity Stem
United Orthopedic Corporation
Orthopedic
252d
Cleared
Aug 06, 2019
BiMobile Dual Mobility System - E-Dur Inserts
Waldemar Link GmbH & Co. KG
Orthopedic
155d
Cleared
Aug 06, 2019
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
Zimmer GmbH
Orthopedic
35d