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
Jan 06, 2022
DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics, Inc.
Orthopedic
28d
Cleared
Dec 21, 2021
Restoration Modular 115mm Conical Distal Stem
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
85d
Cleared
Dec 03, 2021
Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
Total Joint Othopedics, Inc.
Orthopedic
23d
Cleared
Sep 22, 2021
Mpres Neck Preserving Stem
Medacta International S.A.
Orthopedic
233d
Cleared
Aug 05, 2021
EMPHASYS Femoral Stems
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
Corin, Ltd.
Orthopedic
405d
Cleared
Jul 22, 2021
POLARSTEM Cemented Femoral Stem
Smith & Nephew, Inc.
Orthopedic
269d
Cleared
Jul 19, 2021
POLARSTEM Calcar Reamer Guide
Smith & Nephew, Inc.
Orthopedic
61d
Cleared
Apr 28, 2021
BI-MENTUM™ ALTRX® Dual Mobility Liner
Depuy Ireland UC
Orthopedic
147d
Cleared
Apr 16, 2021
Fusion Taper System
Signature Orthopaedics Pty, Ltd.
Orthopedic
360d
Cleared
Apr 01, 2021
KOSMO Femoral Stem
B-One Ortho, Corp.
Orthopedic
192d
Cleared
Feb 03, 2021
EcoFit® Hip System
Implantcast GmbH
Orthopedic
76d
Cleared
Jan 11, 2021
M-Vizion Femoral Revision System Extension
Medacta International S.A.
Orthopedic
222d
Cleared
Dec 28, 2020
Quadra-P
Medacta International S.A.
Orthopedic
101d
Cleared
Dec 08, 2020
Taperloc® Complete Hip Stems
Biomet Orthopedics
Orthopedic
316d
Cleared
Dec 02, 2020
SMS Cementless Stem
Medacta International S.A.
Orthopedic
57d
Cleared
Nov 19, 2020
DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics, Inc.
Orthopedic
27d
Cleared
Sep 18, 2020
SMS Cementless Stem
Medacta International S.A.
Orthopedic
91d
Cleared
Aug 05, 2020
Spartan Hip Stem
Signature Orthopaedics Pty, Ltd.
Orthopedic
300d
Cleared
Aug 04, 2020
Corin Optimized Positioning System (OPS) Femoral
Corin USA
Orthopedic
228d
Cleared
Jul 31, 2020
Cemented Origin Hip Stem
Signature Orthopaedics Pty, Ltd.
Orthopedic
18d
Cleared
Jul 29, 2020
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
Biomet UK, Ltd.
Orthopedic
110d
Cleared
Jun 19, 2020
Cemented TSI Hip Stem
Signature Orthopaedics Pty, Ltd.
Orthopedic
326d
Cleared
Apr 29, 2020
M-Vizion Femoral Revision System Extension
Medacta International S.A.
Orthopedic
299d