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 Smith & Nephew, Inc..

565
Total
565
Cleared
152d
Avg days
1984
Since
565 devices
313–336 of 565
Cleared May 22, 2003
APEX MODULAR ACETABULAR CUP
K031110
Apex Surgical, LLC
Orthopedic · 44d
Cleared May 01, 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733
Zimmer, Inc.
Orthopedic · 52d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Mar 20, 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 04, 2003
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
K021878
Eska America Corp.
Orthopedic · 270d
Cleared Feb 25, 2003
U2 ACETABULAR CUP
K022520
United Orthopedic Corp.
Orthopedic · 210d
Cleared Feb 20, 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 05, 2003
HA PMI FEMORAL HIP STEM
K030048
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079
Zimmer, Inc.
Orthopedic · 27d
Cleared Nov 08, 2002
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 06, 2002
ARCPM 1050 RESIN-HIPS
K023357
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 25, 2002
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
K023375
Pro-Active Healthcare
Orthopedic · 17d
Cleared Oct 04, 2002
RHS ACETABULAR COMPONENT
K022382
Signal Medical Corp.
Orthopedic · 74d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 05, 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891
Zimmer, Inc.
Orthopedic · 90d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 26, 2002
MODIFICATION TO AVALON CUP SYSTEM
K022711
Orthopedic Source, Inc.
Orthopedic · 12d
Cleared Aug 16, 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
K022463
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Jul 30, 2002
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070
Zimmer, Inc.
Orthopedic · 232d
Cleared Jul 24, 2002
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
K021466
Hayes Medical, Inc.
Orthopedic · 78d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
K021970
Implex Corp.
Orthopedic · 25d
Cleared Jul 02, 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Jul 02, 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 12, 2002
ESOP CO-CR FEMORAL HEADS
K021109
Fournitures Hospitalieres
Orthopedic · 68d