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
433–456 of 534
Cleared Jan 19, 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
K945090
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
K945092
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A. E-SERIES HIP- CEMENTLESS USE
K945093
Howmedica, Inc.
Orthopedic · 94d
Cleared Jan 19, 1995
HNR-PC HIP
K945094
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
APC FEMORAL COMPONENT
K945095
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
CDH HIP STEM
K945096
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 18, 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091
Howmedica Corp.
Orthopedic · 93d
Cleared Jan 12, 1995
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K944601
Zimmer, Inc.
Orthopedic · 115d
Cleared Dec 15, 1994
HOWMEDICA SENTRY S TOTAL HIP SYSTEM
K935913
Howmedica, Inc.
Orthopedic · 370d
Cleared Dec 09, 1994
APR II NON POROUS HIP STEM
K944209
Intermedics Orthopedics
Orthopedic · 102d
Cleared Nov 28, 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K935921
Smith & Nephew Richards, Inc.
Orthopedic · 376d
Cleared Nov 14, 1994
MODULAR CERAMIC FEMORAL HEAD
K936256
Stelkast Company
Orthopedic · 319d
Cleared Oct 17, 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586
Biomet, Inc.
Orthopedic · 87d
Cleared Oct 14, 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942
Depuy, Inc.
Orthopedic · 428d
Cleared Oct 06, 1994
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K935452
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 328d
Cleared Oct 04, 1994
APR II FEMORAL COMPONENT (VARIOUS)
K942330
Intermedics Orthopedics
Orthopedic · 141d
Cleared Sep 28, 1994
P.F.C. CERAMIC HIP HEAD
K933275
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 449d
Cleared Sep 12, 1994
TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS
K933108
Landos, Inc.
Orthopedic · 444d
Cleared Aug 18, 1994
CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM
K935193
U.S. Medical Products, Inc.
Orthopedic · 296d
Cleared Jul 12, 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
K941847
Depuy, Inc.
Orthopedic · 89d
Cleared Jul 12, 1994
SOLUTION HIP
K941942
Depuy, Inc.
Orthopedic · 82d
Cleared Jul 06, 1994
STABILITY HIP STEM WITH POROCOAT
K934457
Depuy, Inc.
Orthopedic · 296d
Cleared Jun 16, 1994
MORPHOMETRIC TOTAL HIP PROSTHESIS
K935185
Landos, Inc.
Orthopedic · 233d
Cleared Jun 15, 1994
TITAN DYSPLASIC TOTAL HIP PROSTHESIS
K932935
Landos, Inc.
Orthopedic · 364d