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..
531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
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
Cleared
Jul 06, 2018
BIOLOX delta Option and Extra-long Heads
Microport Orthopedics, Inc.
Orthopedic
206d
Cleared
May 09, 2018
Klassic HD® Hip System
Total Joint Orthopedics, Inc.
Orthopedic
30d
Cleared
Apr 26, 2018
Summit Hip System
DePuy Orthopaedics, Inc.
Orthopedic
448d
Cleared
Mar 28, 2018
CoreHip® System
Aesculap Implants Systems, LLC
Orthopedic
246d
Cleared
Mar 14, 2018
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
Medacta International S.A.
Orthopedic
90d
Cleared
Dec 07, 2017
MasterLoc Stem: Lateralized Plus
Medacta International S.A.
Orthopedic
57d
Cleared
Nov 29, 2017
M-Vizion Femoral Revision System
Medacta International S.A.
Orthopedic
267d
Cleared
Nov 08, 2017
C2 femoral stem
Lima Corporate S.P.A.
Orthopedic
265d
Cleared
Oct 06, 2017
U-Motion II Acetabular System— Additional sizes
United Orthopedic Corporation
Orthopedic
269d
Cleared
Aug 28, 2017
PROCOTYL® PRIME E-CLASS™ XLPE Liner
Microport Orthopedics, Inc.
Orthopedic
126d
Cleared
Aug 25, 2017
Locking Cage, Full XPE Cup
United Orthopedic Corporation
Orthopedic
260d
Cleared
Aug 08, 2017
MiniMAX
Medacta International S.A.
Orthopedic
140d
Cleared
Mar 31, 2017
AMIStem-H Proximal Coating
Medacta International S.A.
Orthopedic
290d
Cleared
Mar 16, 2017
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
Waldemar Link GmbH & Co. KG
Orthopedic
254d
Cleared
Feb 10, 2017
Revision Femoral Stem
Lima Corporate S.P.A.
Orthopedic
284d
Cleared
Oct 26, 2016
Zimmer M/L Taper Hip Prosthesis
Zimmer, Inc.
Orthopedic
113d
Cleared
Jul 08, 2016
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
Zimmer GmbH
Orthopedic
72d
Cleared
Jun 03, 2016
Corin Optimized Positioning System (OPS)
Corin USA
Orthopedic
247d
Cleared
May 20, 2016
MasterLoc Stem
Medacta International
Orthopedic
107d
Cleared
Apr 29, 2016
REVIVAL(TM) Modular Revision Hip Stem
Corin USA
Orthopedic
211d
Cleared
Mar 14, 2016
UCP Stem
United Orthopedic Corporation
Orthopedic
193d
Cleared
Nov 23, 2015
Revision Femoral Stem
Lima Corporate S.P.A.
Orthopedic
150d