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..

534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
289–312 of 534
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
Cleared Sep 06, 2005
SC CERAMIC BALL HEADS
K052237
Orthopedic Alliance, LLC
Orthopedic · 20d
Cleared Jul 19, 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682
Exactech, Inc.
Orthopedic · 26d
Cleared Jul 19, 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 19, 2005
SECUR-FIT MAX AND PLUS MAX HIP STEMS
K051738
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 12, 2005
BIOLOX DELTA CERAMIC FEMORAL HEADS
K051588
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Jun 29, 2005
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
K051411
Biomet, Inc.
Orthopedic · 29d
Cleared May 11, 2005
ALUMINA HEAD
K050556
Fournitures Hospitalieres Industrie
Orthopedic · 69d
Cleared Apr 18, 2005
WAGNER SL REVISION STEM LATERAL
K043356
Zimmer Austin, Inc.
Orthopedic · 133d
Cleared Mar 25, 2005
BIOLOX DELTA CERAMIC HEADS
K042091
Biomet, Inc.
Orthopedic · 234d
Cleared Feb 11, 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
K041940
Howmedica Osteonics Corp.
Orthopedic · 207d
Cleared Feb 11, 2005
CORAIL AMT HIP PROSTHESIS
K042992
DePuy Orthopaedics, Inc.
Orthopedic · 102d
Cleared Nov 17, 2004
ALUMINA HEAD
K042035
Fournitures Hospitalieres Industrie
Orthopedic · 111d
Cleared Nov 16, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K041443
Osteoimplant Technology, Inc.
Orthopedic · 168d
Cleared Nov 09, 2004
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170
Howmedica Osteonics Corp.
Orthopedic · 189d
Cleared Nov 09, 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842
Exactech, Inc.
Orthopedic · 26d