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
169–192 of 531
Cleared Sep 27, 2013
TRINITY ACETABULAR SYSTEM
K131647
Corin USA
Orthopedic · 114d
Cleared Aug 22, 2013
AVENIR CEMENTED HIP STEM
K131884
Zimmer GmbH
Orthopedic · 58d
Cleared Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared May 28, 2013
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
K130343
Corin USA
Orthopedic · 106d
Cleared May 24, 2013
CORIN METAFIX HIP STEM
K130634
Corin USA
Orthopedic · 74d
Cleared May 24, 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared May 01, 2013
BIOLOX DELTA CERAMIC FEMORAL HEADS
K130899
Zimmer GmbH
Orthopedic · 30d
Cleared Apr 19, 2013
PROFEMUR XM DISTAL CENTRALIZER
K130167
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Mar 04, 2013
AVENIR MULLER STEM
K123392
Zimmer GmbH
Orthopedic · 122d
Cleared Feb 12, 2013
TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
K123705
Corin USA
Orthopedic · 71d
Cleared Feb 08, 2013
PROFEMUR TL CLASSIC HIP STEM
K123688
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Feb 05, 2013
PROFEMUR Z CLASSIC STEMS
K123434
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jan 16, 2013
NOVATION CROWN CUP LINERS
K121392
Exactech, Inc.
Orthopedic · 252d
Cleared Nov 21, 2012
CORIN TRINITY-I ACETABULAR SHELL
K122305
Corin USA
Orthopedic · 112d
Cleared Oct 19, 2012
VERSAFITCUP CC TRIO EXTENSION
K122911
Medacta International
Orthopedic · 28d
Cleared Sep 28, 2012
MPACT EXTENSION
K122641
Medacta International
Orthopedic · 30d
Cleared Sep 14, 2012
METAFIX FEMORAL HIP STEM SIZE 1
K121439
Corin USA
Orthopedic · 122d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 09, 2012
PROFEMUR Z REVISION HIP STEM
K121221
Wrightmedicaltechnologyinc
Orthopedic · 108d
Cleared Jul 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211
Smith & Nephew, Inc.
Orthopedic · 177d
Cleared Jun 08, 2012
AMISTEM AND QUADRA - LINE EXTENSION
K121011
Medacta International
Orthopedic · 66d
Cleared May 04, 2012
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
K120362
Corin USA
Orthopedic · 88d
Cleared Apr 18, 2012
VERSAFITCUP CC TRIO-ADDITIONAL LINERS
K120531
Medacta International
Orthopedic · 56d
Cleared Feb 17, 2012
WAGNER CONE PROSTHESIS SYSTEM
K113556
Zimmer GmbH
Orthopedic · 78d