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..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
121–144 of 561
Cleared Sep 11, 2009
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
K091508
Zimmer, Inc.
Orthopedic · 112d
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Jul 22, 2008
TRITANIUM ACETABULAR SHELL SYSTEM
K081171
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared May 15, 2008
ECHELON TITANIUM HIP SYSTEM
K072817
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared May 08, 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417
Smith & Nephew, Inc.
Orthopedic · 135d
Cleared Jan 09, 2008
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K072963
DePuy Orthopaedics, Inc.
Orthopedic · 82d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160
Smith & Nephew, Inc.
General & Plastic Surgery · 162d
Cleared Jul 25, 2007
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
K071784
DePuy Orthopaedics, Inc.
Orthopedic · 23d
Cleared Mar 09, 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369
Biomet, Inc.
Orthopedic · 29d
Cleared Dec 20, 2006
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
K061461
Zimmer, Inc.
Orthopedic · 208d
Cleared Nov 15, 2006
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
K062419
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Oct 24, 2006
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
K062148
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Aug 22, 2006
TRIDENT LARGE DIAMETER HIP SYSTEM
K061434
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Aug 02, 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
K061226
Zimmer, Inc.
Orthopedic · 92d
Cleared Jul 24, 2006
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
K061786
Zimmer, Inc.
Orthopedic · 28d
Cleared Jul 18, 2006
PCA 36MM FEMORAL HEADS
K061168
Howmedica Osteonics Corp.
Orthopedic · 82d
Cleared Jul 17, 2006
DEPUY AML HIP PROSTHESIS
K061833
DePuy Orthopaedics, Inc.
Orthopedic · 18d
Cleared Jul 03, 2006
DYNASTY ACETABULAR SHELL
K061547
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630
Smith & Nephew, Inc.
Orthopedic · 97d
Cleared May 19, 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared May 12, 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040
Zimmer, Inc.
Orthopedic · 126d
Cleared Feb 15, 2006
VERSYS EPOCH FULLCOAT HIP PROSTHESIS
K052321
Zimmer, Inc.
Orthopedic · 174d
Cleared Jan 31, 2006
DEPUY MODULAR M HEADS
K060031
DePuy Orthopaedics, Inc.
Orthopedic · 26d