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
49–72 of 529
Cleared Jan 06, 2022
DePuy Corail AMT Hip Prosthesis
K213839
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 21, 2021
Restoration Modular 115mm Conical Distal Stem
K213129
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 85d
Cleared Dec 03, 2021
Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
K213580
Total Joint Othopedics, Inc.
Orthopedic · 23d
Cleared Sep 22, 2021
Mpres Neck Preserving Stem
K210263
Medacta International S.A.
Orthopedic · 233d
Cleared Aug 05, 2021
EMPHASYS Femoral Stems
K211657
Depuy Ireland UC
Orthopedic · 69d
Cleared Jul 28, 2021
Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
K201657
Corin, Ltd.
Orthopedic · 405d
Cleared Jul 22, 2021
POLARSTEM Cemented Femoral Stem
K203175
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Jul 19, 2021
POLARSTEM Calcar Reamer Guide
K211548
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Apr 28, 2021
BI-MENTUM™ ALTRX® Dual Mobility Liner
K203532
Depuy Ireland UC
Orthopedic · 147d
Cleared Apr 16, 2021
Fusion Taper System
K201047
Signature Orthopaedics Pty, Ltd.
Orthopedic · 360d
Cleared Apr 01, 2021
KOSMO Femoral Stem
K202768
B-One Ortho, Corp.
Orthopedic · 192d
Cleared Feb 03, 2021
EcoFit® Hip System
K203420
Implantcast GmbH
Orthopedic · 76d
Cleared Jan 11, 2021
M-Vizion Femoral Revision System Extension
K201471
Medacta International S.A.
Orthopedic · 222d
Cleared Dec 28, 2020
Quadra-P
K202730
Medacta International S.A.
Orthopedic · 101d
Cleared Dec 08, 2020
Taperloc® Complete Hip Stems
K200196
Biomet Orthopedics
Orthopedic · 316d
Cleared Dec 02, 2020
SMS Cementless Stem
K203041
Medacta International S.A.
Orthopedic · 57d
Cleared Nov 19, 2020
DePuy Corail AMT Hip Prosthesis
K203167
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Sep 18, 2020
SMS Cementless Stem
K201673
Medacta International S.A.
Orthopedic · 91d
Cleared Aug 05, 2020
Spartan Hip Stem
K192883
Signature Orthopaedics Pty, Ltd.
Orthopedic · 300d
Cleared Aug 04, 2020
Corin Optimized Positioning System (OPS) Femoral
K193545
Corin USA
Orthopedic · 228d
Cleared Jul 31, 2020
Cemented Origin Hip Stem
K201951
Signature Orthopaedics Pty, Ltd.
Orthopedic · 18d
Cleared Jul 29, 2020
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
K200959
Biomet UK, Ltd.
Orthopedic · 110d
Cleared Jun 19, 2020
Cemented TSI Hip Stem
K192024
Signature Orthopaedics Pty, Ltd.
Orthopedic · 326d
Cleared Apr 29, 2020
M-Vizion Femoral Revision System Extension
K191816
Medacta International S.A.
Orthopedic · 299d