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..
534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
Cleared
Feb 21, 2008
DEPUY TRI-LOCK BONE PRESERVATION STEM
DePuy Orthopaedics, Inc.
Orthopedic
63d
Cleared
Feb 13, 2008
MECTACER BIOLOX FORTE-FEMORAL HEADS
Medacta International S.A.
Orthopedic
77d
Cleared
Feb 06, 2008
DYNASTY CERAMIC FEMORAL HEAD
Wrightmedicaltechnologyinc
Orthopedic
139d
Cleared
Nov 27, 2007
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
Biomet Manufacturing Corp
Orthopedic
25d
Cleared
Nov 19, 2007
BIOLOX DELTA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
167d
Cleared
Sep 28, 2007
DEPUY DELTA TS CERAMIC FEMORAL HEADS
DePuy Orthopaedics, Inc.
Orthopedic
87d
Cleared
Sep 13, 2007
STRYKER MODULAR HIP SYSTEM
Howmedica Osteonics Corp.
Orthopedic
149d
Cleared
Sep 11, 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
DePuy Orthopaedics, Inc.
Orthopedic
196d
Cleared
Aug 01, 2007
CERAMIC BALL HEADS, 28, 32 AND 36 MM
Plus Orthopedics AG
Orthopedic
120d
Cleared
May 16, 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
Howmedica Osteonics Corp.
Orthopedic
47d
Cleared
Mar 15, 2007
EXACTECH NOVATION CROWN CUP AND LINERS
Exactech, Inc.
Orthopedic
23d
Cleared
Feb 02, 2007
PCA ALUMINA FEMORAL HEADS
Stryker Orthopaedics
Orthopedic
42d
Cleared
Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
Howmedica Osteonics Corp.
Orthopedic
15d
Cleared
Dec 08, 2006
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
Biomet Manufacturing Corp
Orthopedic
67d
Cleared
Nov 30, 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
DePuy Orthopaedics, Inc.
Orthopedic
77d
Cleared
Nov 29, 2006
NOVATION SPLINED RDD FEMORAL STEMS
Exactech, Inc.
Orthopedic
29d
Cleared
Nov 22, 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
Aesculap, Inc.
Orthopedic
75d
Cleared
Sep 01, 2006
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
Portland Orthopaedics Pty. , Ltd.
Orthopedic
88d
Cleared
Jul 14, 2006
SYNERGY HIP SYSTEM
Smith & Nephew, Inc.
General & Plastic Surgery
88d
Cleared
Jul 12, 2006
PATIENT MATCHED HIP STEM
Smith & Nephew, Inc.
Orthopedic
233d
Cleared
Jun 06, 2006
36MM BIOLOX DELTA CERAMIC HEADS
Biomet, Inc.
Orthopedic
27d
Cleared
May 26, 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
Aesculap, Inc.
Orthopedic
52d
Cleared
May 10, 2006
HIPSTAR FEMORAL STEM
Stryker Orthopaedics
Orthopedic
363d
Cleared
Apr 28, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
Ortho Development Corp.
Orthopedic
53d