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 Zimmer, Inc..

531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
265–288 of 531
Cleared Sep 11, 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554
DePuy Orthopaedics, Inc.
Orthopedic · 196d
Cleared May 16, 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 15, 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479
Exactech, Inc.
Orthopedic · 23d
Cleared Feb 02, 2007
PCA ALUMINA FEMORAL HEADS
K063816
Stryker Orthopaedics
Orthopedic · 42d
Cleared Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
K063616
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Dec 08, 2006
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
K062997
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Nov 30, 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Nov 29, 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279
Exactech, Inc.
Orthopedic · 29d
Cleared Nov 22, 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
K062684
Aesculap, Inc.
Orthopedic · 75d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066
Smith & Nephew, Inc.
General & Plastic Surgery · 88d
Cleared Jul 12, 2006
PATIENT MATCHED HIP STEM
K053246
Smith & Nephew, Inc.
Orthopedic · 233d
Cleared Jun 06, 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312
Biomet, Inc.
Orthopedic · 27d
Cleared May 26, 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
K060918
Aesculap, Inc.
Orthopedic · 52d
Cleared May 10, 2006
HIPSTAR FEMORAL STEM
K051223
Stryker Orthopaedics
Orthopedic · 363d
Cleared Apr 28, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577
Ortho Development Corp.
Orthopedic · 53d
Cleared Mar 17, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
K053587
Ortho Development Corp.
Orthopedic · 84d
Cleared Feb 06, 2006
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K060107
Exactech, Inc.
Orthopedic · 24d
Cleared Dec 27, 2005
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
K052787
Exactech, Inc.
Orthopedic · 85d
Cleared Dec 07, 2005
SMITH & NEPHEW PLATFORM HIP STEM
K052275
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Dec 01, 2005
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858
Exactech, Inc.
Orthopedic · 146d
Cleared Nov 18, 2005
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K050398
Exactech, Inc.
Orthopedic · 275d
Cleared Oct 27, 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 27, 2005
ACCOLADE RPS HIP STEM
K052542
Stryker Orthopaedics
Orthopedic · 12d
Cleared Sep 26, 2005
ACCOLADE HFX FEMORAL STEM
K051741
Stryker Orthopaedics
Orthopedic · 90d