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 Zimmer, Inc..

534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
73–96 of 534
Cleared Aug 04, 2020
Corin Optimized Positioning System (OPS) Femoral
K193545
Corin USA
Orthopedic · 228d
Cleared Jul 31, 2020
Cemented Origin Hip Stem
K201951
Signature Orthopaedics Pty, Ltd.
Orthopedic · 18d
Cleared Jul 29, 2020
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
K200959
Biomet UK, Ltd.
Orthopedic · 110d
Cleared Jun 19, 2020
Cemented TSI Hip Stem
K192024
Signature Orthopaedics Pty, Ltd.
Orthopedic · 326d
Cleared Apr 29, 2020
M-Vizion Femoral Revision System Extension
K191816
Medacta International S.A.
Orthopedic · 299d
Cleared Apr 25, 2020
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
K200007
Microport Orthopedics, Inc.
Orthopedic · 114d
Cleared Apr 10, 2020
Zimmer Hip Joint Replacement
K200112
Zimmer GmbH
Orthopedic · 84d
Cleared Feb 28, 2020
Zimmer M/L Taper Hip Prosthesis
K192660
Zimmer, Inc.
Orthopedic · 156d
Cleared Feb 27, 2020
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
K192683
Biomet UK, Ltd.
Orthopedic · 154d
Cleared Jan 16, 2020
MobiliT Cup
K191831
Corin U.S.A. Limited
Orthopedic · 191d
Cleared Jan 09, 2020
AMIStem-C
K193433
Medacta International S.A.
Orthopedic · 30d
Cleared Jan 06, 2020
Quadra-P
K192827
Medacta International S.A.
Orthopedic · 96d
Cleared Dec 26, 2019
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
K193050
Zimmer GmbH
Orthopedic · 55d
Cleared Dec 21, 2019
Acetabular Bone Screws (for MobileLink Acetabular Cup System)
K192559
Waldemar Link GmbH & Co. KG
Orthopedic · 95d
Cleared Dec 18, 2019
Avenir Complete Hip System, Size 0 Coxa Vara
K192189
Zimmer, Inc.
Orthopedic · 127d
Cleared Dec 06, 2019
Avenir Muller Stem, Avenir Cemented Hip Stem
K193030
Zimmer GmbH
Orthopedic · 37d
Cleared Nov 26, 2019
DePuy Corail AMT Hip Prosthesis
K192946
DePuy Orthopaedics, Inc.
Orthopedic · 39d
Cleared Nov 22, 2019
AMIStem-P Short Neck
K192126
Medacta International S.A.
Orthopedic · 108d
Cleared Nov 01, 2019
DePuy Corail AMT Hip Prosthesis
K190344
Depuy(Ireland)
Orthopedic · 260d
Cleared Oct 22, 2019
Exactech Alteon Modular Dual Mobility (MDM) System
K190890
Exactech, Inc.
Orthopedic · 200d
Cleared Oct 07, 2019
PROFEMUR TL2 Stems
K191632
Microport Orthopedics, Inc.
Orthopedic · 110d
Cleared Oct 01, 2019
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
K192416
Zimmer GmbH
Orthopedic · 27d
Cleared Sep 27, 2019
MiniMAX
K192352
Medacta International S.A.
Orthopedic · 29d
Cleared Aug 28, 2019
Signature Ceramic Femoral Head
K190704
Signature Orthopaedics Pty, Ltd.
Orthopedic · 163d