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
121–144 of 529
Cleared Jul 06, 2018
BIOLOX delta Option and Extra-long Heads
K173776
Microport Orthopedics, Inc.
Orthopedic · 206d
Cleared May 09, 2018
Klassic HD® Hip System
K180929
Total Joint Orthopedics, Inc.
Orthopedic · 30d
Cleared Apr 26, 2018
Summit Hip System
K170339
DePuy Orthopaedics, Inc.
Orthopedic · 448d
Cleared Mar 28, 2018
CoreHip® System
K172235
Aesculap Implants Systems, LLC
Orthopedic · 246d
Cleared Mar 14, 2018
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
K173794
Medacta International S.A.
Orthopedic · 90d
Cleared Dec 07, 2017
MasterLoc Stem: Lateralized Plus
K173267
Medacta International S.A.
Orthopedic · 57d
Cleared Nov 29, 2017
M-Vizion Femoral Revision System
K170690
Medacta International S.A.
Orthopedic · 267d
Cleared Aug 08, 2017
MiniMAX
K170845
Medacta International S.A.
Orthopedic · 140d
Cleared Mar 31, 2017
AMIStem-H Proximal Coating
K161635
Medacta International S.A.
Orthopedic · 290d
Cleared Oct 26, 2016
Zimmer M/L Taper Hip Prosthesis
K161830
Zimmer, Inc.
Orthopedic · 113d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902
Smith & Nephew, Inc.
Orthopedic · 55d
Cleared Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739
Smith & Nephew, Inc.
Orthopedic · 111d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653
Biomet, Inc.
Orthopedic · 59d
Cleared Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Oct 10, 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684
Biomet, Inc.
Orthopedic · 122d
Cleared Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared May 24, 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Apr 19, 2013
PROFEMUR XM DISTAL CENTRALIZER
K130167
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Feb 08, 2013
PROFEMUR TL CLASSIC HIP STEM
K123688
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Feb 05, 2013
PROFEMUR Z CLASSIC STEMS
K123434
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 09, 2012
PROFEMUR Z REVISION HIP STEM
K121221
Wrightmedicaltechnologyinc
Orthopedic · 108d