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
97–120 of 529
Cleared Jul 22, 2019
Corin Optimized Position System Functional Hip Analysis (OPS FHA)
K190834
Corin USA
Orthopedic · 112d
Cleared Jul 22, 2019
Revival Modular Hip Stem
K191374
Corin U.S.A. Limited
Orthopedic · 60d
Cleared Jul 18, 2019
Latitud Hip Replacement System
K183532
Meril Healthcare Pvt. , Ltd.
Orthopedic · 211d
Cleared May 30, 2019
MasterLoc Extension
K191145
Medacta International S.A.
Orthopedic · 30d
Cleared May 24, 2019
MobileLink Acetabular Cup System
K182321
Waldemar Link GmbH & Co. KG
Orthopedic · 270d
Cleared May 09, 2019
Delta Dual Mobility System
K181491
Lima Corporate S.P.A.
Orthopedic · 337d
Cleared Apr 02, 2019
Zimmer Biomet Ceramic Heads
K181171
Zimmer, Inc.
Orthopedic · 335d
Cleared Feb 22, 2019
Libertas Acetabular Hooded Liner
K183365
Maxx Orthopedics, Inc.
Orthopedic · 80d
Cleared Feb 14, 2019
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
K182705
B-One Ortho, Corp.
Orthopedic · 140d
Cleared Feb 08, 2019
LINK MP Monoblock Hip Prosthesis
K183141
Waldemar Link GmbH & Co. KG
Orthopedic · 87d
Cleared Jan 30, 2019
Zimmer Segmental System Proximal Femoral Component
K183136
Zimmer, Inc.
Orthopedic · 78d
Cleared Dec 26, 2018
Zimmer Biomet Select Ceramic Heads
K181761
Zimmer, Inc.
Orthopedic · 176d
Cleared Dec 11, 2018
BI-MENTUM dual mobility system
K181744
Serf
Orthopedic · 162d
Cleared Dec 07, 2018
Avenir Complete Hip System
K182048
Zimmer, Inc.
Orthopedic · 129d
Cleared Nov 28, 2018
SMS Femoral Stem
K181693
Medacta International S.A.
Orthopedic · 154d
Cleared Nov 08, 2018
Exactech Alteon Highly Polished Femoral Stem
K182462
Exactech, Inc.
Orthopedic · 59d
Cleared Oct 22, 2018
Quadra P
K181254
Medacta International S.A.
Orthopedic · 164d
Cleared Sep 21, 2018
DePuy Corail AMT Hip Prosthesis
K173960
Depuy France S.A.S.
Orthopedic · 267d
Cleared Sep 20, 2018
MicroPort Orthopedics Total Hip Systems MR Labeling
K173898
Microport Orthopedics Inc. (Mpo)
Orthopedic · 272d
Cleared Sep 14, 2018
Prime E-CLASS XLPE Liner
K181598
Microport Orthopedics, Inc.
Orthopedic · 88d
Cleared Sep 07, 2018
Corin Optimized Positioning System (OPS) Femoral
K181061
Corin USA
Orthopedic · 137d
Cleared Sep 04, 2018
Exactech Alteon Monobloc Revision Stem
K181532
Exactech, Inc.
Orthopedic · 85d
Cleared Aug 30, 2018
b-ONE® Total Hip System
K173380
B-One Ortho, Corp.
Orthopedic · 304d
Cleared Jul 20, 2018
EcoFit Vit E Acetabular System
K180263
Implantcast GmbH
Orthopedic · 171d