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 Smith & Nephew, Inc., Howmedica Osteonics Corp. and Medacta International S.A..

529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
25–48 of 529
Cleared Apr 24, 2024
22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
K234025
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 126d
Cleared Apr 12, 2024
Ceramic Femoral Head
K240452
Microport Orthopedics, Inc.
Orthopedic · 57d
Cleared Mar 11, 2024
28mm/38D MDM X3 Insert for MDM Liner
K233724
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 111d
Cleared Feb 08, 2024
Z1 Hip System
K233476
Orchard Medical Development
Orthopedic · 106d
Cleared Dec 22, 2023
Novae® Dual Mobility System, Hype® Hip System
K223745
Serf
Orthopedic · 373d
Cleared Oct 19, 2023
Actinia® hip stems
K232371
Implantcast GmbH
Orthopedic · 72d
Cleared Oct 11, 2023
EMPHASYS Femoral Stems
K233233
Depuy Ireland UC
Orthopedic · 13d
Cleared Jul 11, 2023
MINIMA S System
K231925
Lima Corporate S.P.A.
Orthopedic · 11d
Cleared Jun 20, 2023
BethaLoc® stem cementless HA
K223103
Implantcast GmbH
Orthopedic · 263d
Cleared Jun 15, 2023
Xerxes Hip Stem
K231109
Xerxes Arthopedix, LLC
Orthopedic · 57d
Cleared May 19, 2023
Exactech® Alteon® Short Tapered Wedge
K221323
Exactech, Inc.
Orthopedic · 378d
Cleared Mar 16, 2023
BENCOX Delta Option Heads
K223828
Corentec Co., Ltd.
Orthopedic · 85d
Cleared Jan 06, 2023
ARTICUL/EZE Ceramic Heads
K222296
Depuy Ireland UC
Orthopedic · 158d
Cleared Jan 05, 2023
U-Motion II Acetabular System-Extension line
K221149
United Orthopedic Corporation
Orthopedic · 260d
Cleared Oct 21, 2022
DePuy Reclaim Monobloc Revision Femoral Stem
K221462
Depuy Ireland UC
Orthopedic · 155d
Cleared Sep 23, 2022
Platform® Acetabular System
K220483
Total Joint Orthopedics, Inc.
Orthopedic · 217d
Cleared Sep 13, 2022
SP-CL Hip Stem and LCU Hip System
K213770
Waldemar Link GmbH & Co. KG
Orthopedic · 285d
Cleared Aug 17, 2022
implaFit® hip stems
K210678
Implantcast GmbH
Orthopedic · 530d
Cleared Jul 22, 2022
DM Converter - TiN coated
K211891
Medacta International S.A.
Orthopedic · 396d
Cleared Jun 03, 2022
BiMobile Instruments (for BiMobile Dual Mobility System)
K211567
Waldemar Link GmbH & Co. KG
Orthopedic · 378d
Cleared May 24, 2022
M-Vizion Monobloc
K212327
Medacta International S.A.
Orthopedic · 301d
Cleared Apr 12, 2022
Amis K Long
K220405
Medacta International S.A.
Orthopedic · 57d
Cleared Apr 11, 2022
MP Reconstruction System
K213675
Waldemar Link GmbH & Co. KG
Orthopedic · 140d
Cleared Apr 07, 2022
Corin MetaFix™ Hip Stem
K212069
Corin U.S.A. Limited
Orthopedic · 279d