FDA Product Code LPH: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Under FDA product code LPH, semi-constrained hip prostheses with metal and polymer bearing surfaces are cleared for total hip arthroplasty.
These implants use a metal femoral head articulating against a polymer — typically ultra-high molecular weight polyethylene — acetabular liner. Metal-on-polymer is the most established bearing couple in hip replacement, with decades of clinical data supporting its performance.
LPH devices are Class II medical devices, regulated under 21 CFR 888.3358 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Zimmer, Inc., Biomet, Inc. and DePuy Orthopaedics, Inc..
564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
Cleared
Jun 20, 2014
ENCOMPASS 10/12 HIP STEM
Ortho Development Corp.
Orthopedic
295d
Cleared
May 19, 2014
CS2 MULTI-HOLE ACETABULAR SHELL
Consensus Orthopedics, Inc.
Orthopedic
26d
Cleared
Apr 11, 2014
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
Renovis Surgical Technologies, LLC
Orthopedic
260d
Cleared
Mar 28, 2014
I-HIP TOTAL HIP SYSTEM
Iconacy Orthopedic Implants, LLC
Orthopedic
225d
Cleared
Mar 13, 2014
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
Total Joint Orthopedics, Inc.
Orthopedic
86d
Cleared
Mar 11, 2014
OVATION TRIBUTE HIP STEM
Ortho Development Corp.
Orthopedic
126d
Cleared
Mar 10, 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
DePuy Orthopaedics, Inc.
Orthopedic
171d
Cleared
Feb 21, 2014
NOVOHIP TOTAL HIP SYSTEM
Novosource, Inc.
Orthopedic
224d
Cleared
Feb 12, 2014
KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
Total Joint Orthopedics, Inc.
Orthopedic
268d
Cleared
Jan 22, 2014
MPACT EXTENSION
Medacta International
Orthopedic
131d
Cleared
Jan 17, 2014
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
Iconacy Orthopedic Implants, LLC
Orthopedic
88d
Cleared
Oct 16, 2013
OVATION 10/12 HIP STEM
Ortho Development Corp.
Orthopedic
187d
Cleared
Sep 19, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
Pipeline Biotechnology
Orthopedic
28d
Cleared
Aug 30, 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
United Orthopedic Corporation
Orthopedic
45d
Cleared
Aug 09, 2013
ICONACY I-HIP SYSTEM
Iconacy Orthopedic Implants, LLC
Orthopedic
95d
Cleared
Jul 01, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
Pipeline Orthopedics
Orthopedic
139d
Cleared
Jun 21, 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
Encore Medical, L.P.
Orthopedic
157d
Cleared
Jun 13, 2013
PIPELINE TOTAL HIP SYSTEM
Pipeline Orthopedics
Orthopedic
43d
Cleared
Jun 06, 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
United Orthopedic Corporation
Orthopedic
135d
Cleared
May 01, 2013
UTF STEM, REDUCED
United Orthopedic Corporation
Orthopedic
163d
Cleared
Apr 30, 2013
DEPUY M-SPEC 36MM FEMORAL HEADS
Depuy Orthopaedics
Orthopedic
427d
Cleared
Apr 19, 2013
ARCOS TROCHANTER BUTTON
Biomet, Inc.
Orthopedic
99d
Cleared
Dec 28, 2012
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
Signature Orthopaedics Pty, Ltd.
Orthopedic
242d
Cleared
Dec 21, 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
Lima Corporate S.P.A.
Orthopedic
445d