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 Medacta International S.A., Smith & Nephew, Inc. and Howmedica Osteonics Corp..

531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
121–144 of 531
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
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 21, 2017
OMNI ARC Anteverted Neck Hip Stem
K172467
Omnilife Science
Orthopedic · 128d
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 Nov 08, 2017
C2 femoral stem
K170473
Lima Corporate S.P.A.
Orthopedic · 265d
Cleared Oct 31, 2017
Trinity™ Dual Mobility System
K170359
Corin U.S.A. Limited
Orthopedic · 267d
Cleared Oct 06, 2017
U-Motion II Acetabular System— Additional sizes
K170089
United Orthopedic Corporation
Orthopedic · 269d
Cleared Sep 25, 2017
Ecofit® Hip System
K163577
Implantcast GmbH
Orthopedic · 279d
Cleared Aug 28, 2017
PROCOTYL® PRIME E-CLASS™ XLPE Liner
K171181
Microport Orthopedics, Inc.
Orthopedic · 126d
Cleared Aug 25, 2017
Locking Cage, Full XPE Cup
K163441
United Orthopedic Corporation
Orthopedic · 260d
Cleared Aug 17, 2017
OMNI Anseris Hip Stem
K171156
Omnilife Science
Orthopedic · 119d
Cleared Aug 08, 2017
MiniMAX
K170845
Medacta International S.A.
Orthopedic · 140d
Cleared Jun 20, 2017
Corin MetaFix Hip Stem
K162942
Corin U.S.A. Limited
Orthopedic · 242d
Cleared Jun 02, 2017
Responsive Orthopedics Total Hip Arthroplasty System
K163585
Responsive Orthopedics, LLC
Orthopedic · 164d
Cleared Mar 31, 2017
AMIStem-H Proximal Coating
K161635
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
K161840
Waldemar Link GmbH & Co. KG
Orthopedic · 254d
Cleared Feb 10, 2017
Revision Femoral Stem
K161226
Lima Corporate S.P.A.
Orthopedic · 284d
Cleared Nov 01, 2016
Initia Total Hip System & BIOCERAM AZUL(R) HEAD
K160895
Kyocera Medical Corporation
Orthopedic · 215d