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
145–168 of 531
Cleared Oct 30, 2015
MasterLoc Stem
K151531
Medacta International
Orthopedic · 144d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902
Smith & Nephew, Inc.
Orthopedic · 55d
Cleared Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
K150066
Exactech, Inc.
Orthopedic · 188d
Cleared Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739
Smith & Nephew, Inc.
Orthopedic · 111d
Cleared Apr 20, 2015
PROFEMUR Preserve Size 1-3 Hip Stems
K150133
Microport Orthopedics, Inc.
Orthopedic · 89d
Cleared Apr 10, 2015
PROFEMUR Preserve Classic Stem
K150302
Microport Orthopedics, Inc.
Orthopedic · 63d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Jan 27, 2015
MasterSL femoral stem
K143509
Lima Corporate S.P.A.
Orthopedic · 47d
Cleared Nov 06, 2014
LINK MP RECONSTRUCTION PROSTHESIS
K142187
Waldemar Link GmbH & Co. KG
Orthopedic · 90d
Cleared Sep 12, 2014
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K141235
Microport Orthopedics, Inc.
Orthopedic · 122d
Cleared Aug 28, 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
K141821
Exactech, Inc.
Orthopedic · 52d
Cleared Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 06, 2014
MINIMA S SYSTEM
K141327
Lima Corporate S.P.A.
Orthopedic · 77d
Cleared Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674
Exactech, Inc.
Orthopedic · 104d
Cleared Jun 10, 2014
MASTERSL FEMORAL STEM
K140975
Lima Corporate S.P.A.
Orthopedic · 55d
Cleared May 30, 2014
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
K140676
Microport Orthopedics, Inc.
Orthopedic · 73d
Cleared Apr 03, 2014
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
K140043
Microport Orthopedics, Inc.
Orthopedic · 85d
Cleared Dec 16, 2013
CORIN METAFIX HIP STEM
K131952
Corin USA
Orthopedic · 172d
Cleared Dec 16, 2013
CORIN MINIHIP STEM
K131986
Corin USA
Orthopedic · 171d
Cleared Nov 04, 2013
MECTACER BIOLOX OPTION HEADS
K131518
Medacta International
Orthopedic · 160d
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 Oct 01, 2013
MPACT DM LINER CONVERTER
K131458
Medacta International
Orthopedic · 134d