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 24, 2024
22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
126d
Cleared
Apr 12, 2024
Ceramic Femoral Head
Microport Orthopedics, Inc.
Orthopedic
57d
Cleared
Mar 11, 2024
28mm/38D MDM X3 Insert for MDM Liner
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
111d
Cleared
Feb 08, 2024
Z1 Hip System
Orchard Medical Development
Orthopedic
106d
Cleared
Dec 22, 2023
Novae® Dual Mobility System, Hype® Hip System
Serf
Orthopedic
373d
Cleared
Oct 19, 2023
Actinia® hip stems
Implantcast GmbH
Orthopedic
72d
Cleared
Oct 11, 2023
EMPHASYS Femoral Stems
Depuy Ireland UC
Orthopedic
13d
Cleared
Jul 11, 2023
MINIMA S System
Lima Corporate S.P.A.
Orthopedic
11d
Cleared
Jun 20, 2023
BethaLoc® stem cementless HA
Implantcast GmbH
Orthopedic
263d
Cleared
Jun 15, 2023
Xerxes Hip Stem
Xerxes Arthopedix, LLC
Orthopedic
57d
Cleared
May 19, 2023
Exactech® Alteon® Short Tapered Wedge
Exactech, Inc.
Orthopedic
378d
Cleared
Mar 16, 2023
BENCOX Delta Option Heads
Corentec Co., Ltd.
Orthopedic
85d
Cleared
Jan 06, 2023
ARTICUL/EZE Ceramic Heads
Depuy Ireland UC
Orthopedic
158d
Cleared
Jan 05, 2023
U-Motion II Acetabular System-Extension line
United Orthopedic Corporation
Orthopedic
260d
Cleared
Oct 21, 2022
DePuy Reclaim Monobloc Revision Femoral Stem
Depuy Ireland UC
Orthopedic
155d
Cleared
Sep 23, 2022
Platform® Acetabular System
Total Joint Orthopedics, Inc.
Orthopedic
217d
Cleared
Sep 13, 2022
SP-CL Hip Stem and LCU Hip System
Waldemar Link GmbH & Co. KG
Orthopedic
285d
Cleared
Aug 17, 2022
implaFit® hip stems
Implantcast GmbH
Orthopedic
530d
Cleared
Jul 22, 2022
DM Converter - TiN coated
Medacta International S.A.
Orthopedic
396d
Cleared
Jun 03, 2022
BiMobile Instruments (for BiMobile Dual Mobility System)
Waldemar Link GmbH & Co. KG
Orthopedic
378d
Cleared
May 24, 2022
M-Vizion Monobloc
Medacta International S.A.
Orthopedic
301d
Cleared
Apr 12, 2022
Amis K Long
Medacta International S.A.
Orthopedic
57d
Cleared
Apr 11, 2022
MP Reconstruction System
Waldemar Link GmbH & Co. KG
Orthopedic
140d
Cleared
Apr 07, 2022
Corin MetaFix™ Hip Stem
Corin U.S.A. Limited
Orthopedic
279d