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 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
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
Oct 26, 2016
Zimmer M/L Taper Hip Prosthesis
Zimmer, Inc.
Orthopedic
113d
Cleared
Sep 03, 2015
REDAPT¿ Revision Femoral System
Smith & Nephew, Inc.
Orthopedic
55d
Cleared
Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
Smith & Nephew, Inc.
Orthopedic
111d
Cleared
Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
Smith & Nephew, Inc.
Orthopedic
147d
Cleared
Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
Biomet, Inc.
Orthopedic
59d
Cleared
Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
Smith & Nephew, Inc.
Orthopedic
78d
Cleared
Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
Smith & Nephew, Inc.
Orthopedic
206d
Cleared
Oct 10, 2013
BIOLOX(R) DELTA CERAMIC HEADS
Biomet, Inc.
Orthopedic
122d
Cleared
Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
Wrightmedicaltechnologyinc
Orthopedic
139d
Cleared
May 24, 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
Wrightmedicaltechnologyinc
Orthopedic
45d
Cleared
Apr 19, 2013
PROFEMUR XM DISTAL CENTRALIZER
Wrightmedicaltechnologyinc
Orthopedic
86d
Cleared
Feb 08, 2013
PROFEMUR TL CLASSIC HIP STEM
Wrightmedicaltechnologyinc
Orthopedic
67d
Cleared
Feb 05, 2013
PROFEMUR Z CLASSIC STEMS
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
Smith & Nephew, Inc.
Orthopedic
28d
Cleared
Aug 09, 2012
PROFEMUR Z REVISION HIP STEM
Wrightmedicaltechnologyinc
Orthopedic
108d