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