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
Sep 27, 2013
TRINITY ACETABULAR SYSTEM
Corin USA
Orthopedic
114d
Cleared
Aug 22, 2013
AVENIR CEMENTED HIP STEM
Zimmer GmbH
Orthopedic
58d
Cleared
Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
Wrightmedicaltechnologyinc
Orthopedic
139d
Cleared
May 28, 2013
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
Corin USA
Orthopedic
106d
Cleared
May 24, 2013
CORIN METAFIX HIP STEM
Corin USA
Orthopedic
74d
Cleared
May 24, 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
Wrightmedicaltechnologyinc
Orthopedic
45d
Cleared
May 01, 2013
BIOLOX DELTA CERAMIC FEMORAL HEADS
Zimmer GmbH
Orthopedic
30d
Cleared
Apr 19, 2013
PROFEMUR XM DISTAL CENTRALIZER
Wrightmedicaltechnologyinc
Orthopedic
86d
Cleared
Mar 04, 2013
AVENIR MULLER STEM
Zimmer GmbH
Orthopedic
122d
Cleared
Feb 12, 2013
TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
Corin USA
Orthopedic
71d
Cleared
Feb 08, 2013
PROFEMUR TL CLASSIC HIP STEM
Wrightmedicaltechnologyinc
Orthopedic
67d
Cleared
Feb 05, 2013
PROFEMUR Z CLASSIC STEMS
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Jan 16, 2013
NOVATION CROWN CUP LINERS
Exactech, Inc.
Orthopedic
252d
Cleared
Nov 21, 2012
CORIN TRINITY-I ACETABULAR SHELL
Corin USA
Orthopedic
112d
Cleared
Oct 19, 2012
VERSAFITCUP CC TRIO EXTENSION
Medacta International
Orthopedic
28d
Cleared
Sep 28, 2012
MPACT EXTENSION
Medacta International
Orthopedic
30d
Cleared
Sep 14, 2012
METAFIX FEMORAL HIP STEM SIZE 1
Corin USA
Orthopedic
122d
Cleared
Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
Smith & Nephew, Inc.
Orthopedic
28d
Cleared
Aug 09, 2012
PROFEMUR Z REVISION HIP STEM
Wrightmedicaltechnologyinc
Orthopedic
108d
Cleared
Jul 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
Smith & Nephew, Inc.
Orthopedic
177d
Cleared
Jun 08, 2012
AMISTEM AND QUADRA - LINE EXTENSION
Medacta International
Orthopedic
66d
Cleared
May 04, 2012
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
Corin USA
Orthopedic
88d
Cleared
Apr 18, 2012
VERSAFITCUP CC TRIO-ADDITIONAL LINERS
Medacta International
Orthopedic
56d
Cleared
Feb 17, 2012
WAGNER CONE PROSTHESIS SYSTEM
Zimmer GmbH
Orthopedic
78d