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
Cleared
Nov 20, 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
Johnson & Johnson Professionals, Inc.
Orthopedic
78d
Cleared
Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
Sulzer Orthopedics, Inc.
Orthopedic
88d
Cleared
Nov 03, 1997
PARTNERSHIP REVISION FEMORAL STEMS
Howmedica Corp.
Orthopedic
90d
Cleared
Oct 15, 1997
ZIRCONIA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
90d
Cleared
Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
Sulzer Orthopedics, Inc.
Orthopedic
78d
Cleared
Sep 23, 1997
V40 ZIRCONIA FEMORAL HEADS
Howmedica, Inc.
Orthopedic
90d
Cleared
Aug 22, 1997
HEADLOC CERAMIC HEAD
Ortho Development Corp.
Orthopedic
179d
Cleared
Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
Biomet, Inc.
Orthopedic
279d
Cleared
Jul 30, 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
Zimmer, Inc.
Orthopedic
79d
Cleared
Jul 16, 1997
OSTEONICS ANTEVERTED NECK HIP STEM
Osteonics Corp.
Orthopedic
83d
Cleared
Jul 09, 1997
OSTEONICS ALUMINA C-TAPER HEAD
Osteonics Corp.
Orthopedic
84d
Cleared
Jul 09, 1997
HEADLOC CERAMIC HEAD
Ortho Development Corp.
Orthopedic
83d
Cleared
Jul 09, 1997
HEADLOC CERAMIC FEMORAL HEADS
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
Encore Orthopedics, Inc.
Orthopedic
193d
Cleared
May 02, 1997
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
Stelkast Company
Orthopedic
81d
Cleared
Apr 09, 1997
RELIANCE PF FEMORAL STEMS
Howmedica Corp.
Orthopedic
78d
Cleared
Apr 08, 1997
NATURAL-HIP SYSTEM COCR REVISION STEM
Intermedics Orthopedics
Orthopedic
82d
Cleared
Jan 27, 1997
NATURAL-HIP SYSTEM COCR STEM
Intermedics Orthopedics
Orthopedic
87d
Cleared
Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
Depuy, Inc.
Orthopedic
60d
Cleared
Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
Wrightmedicaltechnologyinc
Orthopedic
82d
Cleared
Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
Zimmer, Inc.
Orthopedic
287d
Cleared
Aug 29, 1996
P.F.C. CERAMIC HIP HEAD
Johnson & Johnson Professionals, Inc.
Orthopedic
79d
Cleared
Aug 19, 1996
ZWEYMUELLER SL FEMORAL HIP STEM
Intermedics Orthopedics
Orthopedic
81d
Cleared
Aug 05, 1996
WAGNER REVISION STEM
Intermedics Orthopedics
Orthopedic
175d