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 Medacta International S.A., Smith & Nephew, Inc. and Howmedica Osteonics Corp..
531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
Cleared
Oct 26, 2016
Zimmer M/L Taper Hip Prosthesis
Zimmer, Inc.
Orthopedic
113d
Cleared
Jul 08, 2016
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
Zimmer GmbH
Orthopedic
72d
Cleared
Jun 03, 2016
Corin Optimized Positioning System (OPS)
Corin USA
Orthopedic
247d
Cleared
May 20, 2016
MasterLoc Stem
Medacta International
Orthopedic
107d
Cleared
Apr 29, 2016
REVIVAL(TM) Modular Revision Hip Stem
Corin USA
Orthopedic
211d
Cleared
Mar 14, 2016
UCP Stem
United Orthopedic Corporation
Orthopedic
193d
Cleared
Mar 10, 2016
OMNI Skirted Heads
Omni Life Science, Inc.
Orthopedic
160d
Cleared
Feb 26, 2016
ICONACY(TM) I-Hip (TM)
Iconacy Orthopedic Implants, LLC
Orthopedic
284d
Cleared
Jan 21, 2016
Corin Metafix Hip Stem
Corin U.S.A. Limited
Orthopedic
59d
Cleared
Nov 23, 2015
Revision Femoral Stem
Lima Corporate S.P.A.
Orthopedic
150d
Cleared
Oct 30, 2015
MasterLoc Stem
Medacta International
Orthopedic
144d
Cleared
Sep 09, 2015
TGM Biolox delta Ceramic Heads
Tgm Medical, Inc.
Orthopedic
187d
Cleared
Sep 03, 2015
REDAPT¿ Revision Femoral System
Smith & Nephew, Inc.
Orthopedic
55d
Cleared
Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
Exactech, Inc.
Orthopedic
188d
Cleared
Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
Smith & Nephew, Inc.
Orthopedic
111d
Cleared
Apr 20, 2015
PROFEMUR Preserve Size 1-3 Hip Stems
Microport Orthopedics, Inc.
Orthopedic
89d
Cleared
Apr 10, 2015
PROFEMUR Preserve Classic Stem
Microport Orthopedics, Inc.
Orthopedic
63d
Cleared
Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
Smith & Nephew, Inc.
Orthopedic
147d
Cleared
Feb 09, 2015
Excia Total Hip System
Aesculap Implant Systems, LLC
Orthopedic
27d
Cleared
Jan 27, 2015
MasterSL femoral stem
Lima Corporate S.P.A.
Orthopedic
47d
Cleared
Jan 15, 2015
CI../..X liner for NOVAE Dual Mobility Acetabular Cup
Serf
Orthopedic
118d
Cleared
Dec 23, 2014
Klassic HD Hip System
Total Joint Othopedics, Inc.
Orthopedic
25d
Cleared
Nov 21, 2014
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
Merete Medical GmbH
Orthopedic
178d
Cleared
Nov 06, 2014
LINK MP RECONSTRUCTION PROSTHESIS
Waldemar Link GmbH & Co. KG
Orthopedic
90d