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..
562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
Cleared
Jul 17, 2017
U2 Femoral Head
United Orthopedic Corporation
Orthopedic
266d
Cleared
Jun 26, 2017
PROCOTYL® PRIME Acetabular Cup System
Microport Orthopedics, Inc.
Orthopedic
132d
Cleared
Jun 14, 2017
iTotal® Hip Replacement System
Conformis, Inc.
Orthopedic
258d
Cleared
Jun 08, 2017
UTF Stem, reduced, #0, #00
United Orthopedic Corporation
Orthopedic
205d
Cleared
May 26, 2016
G7 Dual Mobility System, Active Articulation System
Biomet, Inc.
Orthopedic
29d
Cleared
Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
Smith & Nephew, Inc.
Orthopedic
236d
Cleared
Oct 06, 2015
Arcos One-piece Femoral Revision System
Biomet, Inc.
Orthopedic
116d
Cleared
Sep 03, 2015
Exactech® Novation® Crown Cup®
Exactech, Inc.
Orthopedic
412d
Cleared
Aug 13, 2015
U2 Hip Stem, Ti Porous Coated, Matrix
United Orthopedic Corporation
Orthopedic
87d
Cleared
Aug 13, 2015
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
Zimmer, Inc.
Orthopedic
76d
Cleared
May 01, 2015
G7 Dual Mobility System
Biomet, Inc.
Orthopedic
60d
Cleared
Mar 25, 2015
Echo Bi-Metric Microplasty Line Extension
Biomet, Inc.
Orthopedic
27d
Cleared
Mar 02, 2015
Mpact Double Mobility System
Medacta International
Orthopedic
89d
Cleared
Feb 27, 2015
PROCOTYL L-O ACETABULAR SYSTEM
Microport Orthopedics, Inc.
Orthopedic
207d
Cleared
Feb 10, 2015
G7 Freedom and Offset Liners, Freedom Head, Size 32
Biomet, Inc.
Orthopedic
131d
Cleared
Dec 18, 2014
Echo Bi-Metric Microplasty Hip System
Biomet, Inc.
Orthopedic
59d
Cleared
Dec 11, 2014
G7 OSSEOTI ACETUBLAR SHELLS
Biomet, Inc.
Orthopedic
268d
Cleared
Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
Exactech, Inc.
Orthopedic
27d
Cleared
Jun 30, 2014
DELTA TT ACETABULAR SYSTEM
Lima Corporate S.P.A.
Orthopedic
33d
Cleared
Jun 20, 2014
ENCOMPASS 10/12 HIP STEM
Ortho Development Corp.
Orthopedic
295d
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
Jan 22, 2014
MPACT EXTENSION
Medacta International
Orthopedic
131d
Cleared
Oct 16, 2013
OVATION 10/12 HIP STEM
Ortho Development Corp.
Orthopedic
187d