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 Dec 05, 1997
MERIDIAN TITANIUM FEMORAL STEMS
K972228
Howmedica, Inc.
Orthopedic · 175d
Cleared Nov 24, 1997
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
K973261
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Nov 20, 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307
Johnson & Johnson Professionals, Inc.
Orthopedic · 78d
Cleared Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Nov 03, 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893
Howmedica Corp.
Orthopedic · 90d
Cleared Oct 15, 1997
ZIRCONIA CERAMIC FEMORAL HEAD
K972690
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
K972637
Sulzer Orthopedics, Inc.
Orthopedic · 78d
Cleared Sep 23, 1997
V40 ZIRCONIA FEMORAL HEADS
K972361
Howmedica, Inc.
Orthopedic · 90d
Cleared Aug 22, 1997
HEADLOC CERAMIC HEAD
K970675
Ortho Development Corp.
Orthopedic · 179d
Cleared Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431
Biomet, Inc.
Orthopedic · 279d
Cleared Jul 30, 1997
WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
K971721
Whiteside Biomechanics, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752
Zimmer, Inc.
Orthopedic · 79d
Cleared Jul 16, 1997
ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS
K971414
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 91d
Cleared Jul 16, 1997
OSTEONICS ANTEVERTED NECK HIP STEM
K971497
Osteonics Corp.
Orthopedic · 83d
Cleared Jul 09, 1997
OSTEONICS ALUMINA C-TAPER HEAD
K971409
Osteonics Corp.
Orthopedic · 84d
Cleared Jul 09, 1997
HEADLOC CERAMIC HEAD
K971426
Ortho Development Corp.
Orthopedic · 83d
Cleared Jul 09, 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435
Ortho Development Corp.
Orthopedic · 82d
Cleared Jun 27, 1997
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
K965002
Encore Orthopedics, Inc.
Orthopedic · 193d
Cleared Jun 05, 1997
22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
K970846
Landos, Inc.
Orthopedic · 90d
Cleared May 02, 1997
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
K970490
Stelkast Company
Orthopedic · 81d
Cleared Apr 09, 1997
RELIANCE PF FEMORAL STEMS
K970200
Howmedica Corp.
Orthopedic · 78d
Cleared Apr 08, 1997
NATURAL-HIP SYSTEM COCR REVISION STEM
K970166
Intermedics Orthopedics
Orthopedic · 82d
Cleared Feb 19, 1997
PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
K970346
Kairos Orthopaedics
Orthopedic · 20d
Cleared Jan 27, 1997
NATURAL-HIP SYSTEM COCR STEM
K964357
Intermedics Orthopedics
Orthopedic · 87d