LPH · Class II · 21 CFR 888.3358

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
145–168 of 564
Cleared Jun 20, 2014
ENCOMPASS 10/12 HIP STEM
K132697
Ortho Development Corp.
Orthopedic · 295d
Cleared May 19, 2014
CS2 MULTI-HOLE ACETABULAR SHELL
K141043
Consensus Orthopedics, Inc.
Orthopedic · 26d
Cleared Apr 11, 2014
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
K132312
Renovis Surgical Technologies, LLC
Orthopedic · 260d
Cleared Mar 28, 2014
I-HIP TOTAL HIP SYSTEM
K132572
Iconacy Orthopedic Implants, LLC
Orthopedic · 225d
Cleared Mar 13, 2014
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
K133832
Total Joint Orthopedics, Inc.
Orthopedic · 86d
Cleared Mar 11, 2014
OVATION TRIBUTE HIP STEM
K133386
Ortho Development Corp.
Orthopedic · 126d
Cleared Mar 10, 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959
DePuy Orthopaedics, Inc.
Orthopedic · 171d
Cleared Feb 21, 2014
NOVOHIP TOTAL HIP SYSTEM
K132158
Novosource, Inc.
Orthopedic · 224d
Cleared Feb 12, 2014
KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
K131454
Total Joint Orthopedics, Inc.
Orthopedic · 268d
Cleared Jan 22, 2014
MPACT EXTENSION
K132879
Medacta International
Orthopedic · 131d
Cleared Jan 17, 2014
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
K133228
Iconacy Orthopedic Implants, LLC
Orthopedic · 88d
Cleared Oct 16, 2013
OVATION 10/12 HIP STEM
K131022
Ortho Development Corp.
Orthopedic · 187d
Cleared Sep 19, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K132626
Pipeline Biotechnology
Orthopedic · 28d
Cleared Aug 30, 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
K132207
United Orthopedic Corporation
Orthopedic · 45d
Cleared Aug 09, 2013
ICONACY I-HIP SYSTEM
K131279
Iconacy Orthopedic Implants, LLC
Orthopedic · 95d
Cleared Jul 01, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K130353
Pipeline Orthopedics
Orthopedic · 139d
Cleared Jun 21, 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099
Encore Medical, L.P.
Orthopedic · 157d
Cleared Jun 13, 2013
PIPELINE TOTAL HIP SYSTEM
K131237
Pipeline Orthopedics
Orthopedic · 43d
Cleared Jun 06, 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149
United Orthopedic Corporation
Orthopedic · 135d
Cleared May 01, 2013
UTF STEM, REDUCED
K123550
United Orthopedic Corporation
Orthopedic · 163d
Cleared Apr 30, 2013
DEPUY M-SPEC 36MM FEMORAL HEADS
K120599
Depuy Orthopaedics
Orthopedic · 427d
Cleared Apr 19, 2013
ARCOS TROCHANTER BUTTON
K130063
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
K121297
Signature Orthopaedics Pty, Ltd.
Orthopedic · 242d
Cleared Dec 21, 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898
Lima Corporate S.P.A.
Orthopedic · 445d