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 Howmedica Osteonics Corp..

531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
433–456 of 531
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 14, 1994
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617
Exactech, Inc.
Orthopedic · 438d
Cleared May 27, 1994
SLT FEMORAL HEAD
K932222
Dow Corning Wright
Orthopedic · 385d
Cleared May 18, 1994
CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM
K933499
U.S. Medical Products, Inc.
Orthopedic · 303d
Cleared May 18, 1994
KIRSCHNER ZIRCONIA FEMORAL HEAD
K934694
Kirschner Medical Corp.
Orthopedic · 230d
Cleared Apr 19, 1994
LINK CERAMIC HEADS 12/14 X 32MM
K931571
Link America, Inc.
Orthopedic · 385d
Cleared Apr 19, 1994
APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
K933203
Intermedics Orthopedics
Orthopedic · 292d
Cleared Mar 30, 1994
KINAMED REALITY TOTAL HIP SYSTEM
K922247
Kinamed, Inc.
Orthopedic · 686d
Cleared Mar 29, 1994
TECHMEDICA CONTINUUM HIP SYSTEM
K931929
Techmedica, Inc.
Orthopedic · 347d
Cleared Mar 28, 1994
LINK CERAMIC HEADS 14/16 X 32MM
K931572
Link America, Inc.
Orthopedic · 363d
Cleared Mar 10, 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345
Biomet, Inc.
Orthopedic · 504d
Cleared Mar 10, 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395
Depuy, Inc.
Orthopedic · 444d
Cleared Mar 10, 1994
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
K932519
Osteonics Corp.
Orthopedic · 289d
Cleared Feb 22, 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K930788
Smith & Nephew Richards, Inc.
Orthopedic · 371d
Cleared Feb 16, 1994
MALLORY-HEAD TOTAL HIP SYSTEM
K921181
Biomet, Inc.
Orthopedic · 708d
Cleared Feb 16, 1994
BIMETRIC TOTAL HIP SYSTEM
K921224
Biomet, Inc.
Orthopedic · 705d
Cleared Feb 16, 1994
INTEGRAL TOTAL HIP SYSTEM
K921225
Biomet, Inc.
Orthopedic · 705d
Cleared Feb 09, 1994
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
K931189
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 337d
Cleared Jan 07, 1994
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED
K925682
Biopro, Inc.
Orthopedic · 427d
Cleared Jan 07, 1994
SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS
K930963
Encore Orthopedics, Inc.
Orthopedic · 317d
Cleared Oct 04, 1993
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR
K930712
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 235d
Cleared Jul 27, 1993
MULLER STRAIGHT STEM FEMORAL PROSTHESIS
K923808
Techmedica, Inc.
Orthopedic · 363d