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
361–384 of 531
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 04, 1994
APR II FEMORAL COMPONENT (VARIOUS)
K942330
Intermedics Orthopedics
Orthopedic · 141d
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
KIRSCHNER ZIRCONIA FEMORAL HEAD
K934694
Kirschner Medical Corp.
Orthopedic · 230d
Cleared Apr 19, 1994
APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
K933203
Intermedics Orthopedics
Orthopedic · 292d
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 Jan 07, 1994
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED
K925682
Biopro, Inc.
Orthopedic · 427d