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..

534
Total
534
Cleared
144d
Avg days
1985
Since
534 devices
385–408 of 534
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
Cleared Jan 27, 1997
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
K964395
Hayes Medical, Inc.
Orthopedic · 84d
Cleared Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704
Depuy, Inc.
Orthopedic · 60d
Cleared Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Dec 27, 1996
CORAIL
K953111
Landos, Inc.
Orthopedic · 543d
Cleared Dec 27, 1996
WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
K964150
Whiteside Biomechanics, Inc.
Orthopedic · 72d
Cleared Oct 08, 1996
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K955877
Zimmer, Inc.
Orthopedic · 287d
Cleared Aug 29, 1996
P.F.C. CERAMIC HIP HEAD
K962248
Johnson & Johnson Professionals, Inc.
Orthopedic · 79d