LZO · Class II · 21 CFR 888.3353

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
145–168 of 531
Cleared Oct 26, 2016
Zimmer M/L Taper Hip Prosthesis
K161830
Zimmer, Inc.
Orthopedic · 113d
Cleared Jul 08, 2016
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
K161192
Zimmer GmbH
Orthopedic · 72d
Cleared Jun 03, 2016
Corin Optimized Positioning System (OPS)
K152893
Corin USA
Orthopedic · 247d
Cleared May 20, 2016
MasterLoc Stem
K160289
Medacta International
Orthopedic · 107d
Cleared Apr 29, 2016
REVIVAL(TM) Modular Revision Hip Stem
K152903
Corin USA
Orthopedic · 211d
Cleared Mar 14, 2016
UCP Stem
K152530
United Orthopedic Corporation
Orthopedic · 193d
Cleared Mar 10, 2016
OMNI Skirted Heads
K152919
Omni Life Science, Inc.
Orthopedic · 160d
Cleared Feb 26, 2016
ICONACY(TM) I-Hip (TM)
K151307
Iconacy Orthopedic Implants, LLC
Orthopedic · 284d
Cleared Jan 21, 2016
Corin Metafix Hip Stem
K153381
Corin U.S.A. Limited
Orthopedic · 59d
Cleared Nov 23, 2015
Revision Femoral Stem
K151739
Lima Corporate S.P.A.
Orthopedic · 150d
Cleared Oct 30, 2015
MasterLoc Stem
K151531
Medacta International
Orthopedic · 144d
Cleared Sep 09, 2015
TGM Biolox delta Ceramic Heads
K150576
Tgm Medical, Inc.
Orthopedic · 187d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902
Smith & Nephew, Inc.
Orthopedic · 55d
Cleared Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
K150066
Exactech, Inc.
Orthopedic · 188d
Cleared Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739
Smith & Nephew, Inc.
Orthopedic · 111d
Cleared Apr 20, 2015
PROFEMUR Preserve Size 1-3 Hip Stems
K150133
Microport Orthopedics, Inc.
Orthopedic · 89d
Cleared Apr 10, 2015
PROFEMUR Preserve Classic Stem
K150302
Microport Orthopedics, Inc.
Orthopedic · 63d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Feb 09, 2015
Excia Total Hip System
K150062
Aesculap Implant Systems, LLC
Orthopedic · 27d
Cleared Jan 27, 2015
MasterSL femoral stem
K143509
Lima Corporate S.P.A.
Orthopedic · 47d
Cleared Jan 15, 2015
CI../..X liner for NOVAE Dual Mobility Acetabular Cup
K142675
Serf
Orthopedic · 118d
Cleared Dec 23, 2014
Klassic HD Hip System
K143407
Total Joint Othopedics, Inc.
Orthopedic · 25d
Cleared Nov 21, 2014
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
K141377
Merete Medical GmbH
Orthopedic · 178d
Cleared Nov 06, 2014
LINK MP RECONSTRUCTION PROSTHESIS
K142187
Waldemar Link GmbH & Co. KG
Orthopedic · 90d