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..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
97–120 of 564
Cleared Nov 21, 2017
Smith & Nephew, Inc. REDAPT Augments
K171073
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Oct 24, 2017
UTS Stem
K172251
United Orthopedic Corporation
Orthopedic · 90d
Cleared Oct 17, 2017
Bencox Mirabo Cup System
K172806
Corentec Co., Ltd.
Orthopedic · 29d
Cleared Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Oct 02, 2017
Trident® II Acetabular System
K171768
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic · 110d
Cleared Sep 21, 2017
iNSitu Total Hip System
K172501
Theken Companies, LLC
Orthopedic · 34d
Cleared Jul 24, 2017
Klassic HD® Hip System
K171962
Total Joint Othopedics, Inc.
Orthopedic · 24d
Cleared Jul 17, 2017
U2 Femoral Head
K162957
United Orthopedic Corporation
Orthopedic · 266d
Cleared Jun 26, 2017
PROCOTYL® PRIME Acetabular Cup System
K170444
Microport Orthopedics, Inc.
Orthopedic · 132d
Cleared Jun 14, 2017
iTotal® Hip Replacement System
K162719
Conformis, Inc.
Orthopedic · 258d
Cleared Jun 08, 2017
UTF Stem, reduced, #0, #00
K163193
United Orthopedic Corporation
Orthopedic · 205d
Cleared Dec 05, 2016
Bencox M Stem Lateralized & Bencox Mirabo Cup System
K162127
Corentec Co., Ltd.
Orthopedic · 126d
Cleared Oct 19, 2016
Klassic HD Hip System
K161073
Total Joint Othopedics, Inc.
Orthopedic · 184d
Cleared Oct 14, 2016
iNSitu Total Hip System
K161184
Theken Companies, LLC
Orthopedic · 170d
Cleared Oct 14, 2016
Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
K161569
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic · 129d
Cleared Jul 27, 2016
The Progressive Orthopaedic Total Hip System
K151424
The Progressive Orthopaedic Company, LLC
Orthopedic · 426d
Cleared May 26, 2016
G7 Dual Mobility System, Active Articulation System
K161190
Biomet, Inc.
Orthopedic · 29d
Cleared May 25, 2016
Stryker Orthopaedics Hip Systems Labeling Update
K153345
Stryker Orthopaedics
Orthopedic · 188d
Cleared May 17, 2016
Escalade Legend Acetabular Shell
K161080
Ortho Development Corporation
Orthopedic · 29d
Cleared Apr 29, 2016
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
K152084
Corentec Co., Ltd.
Orthopedic · 277d
Cleared Apr 08, 2016
ICONACY(TM) I-Hip(TM)
K160266
Iconacy Orthopedic Implants, LLC
Orthopedic · 66d
Cleared Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
K150790
Smith & Nephew, Inc.
Orthopedic · 236d
Cleared Oct 06, 2015
Arcos One-piece Femoral Revision System
K151603
Biomet, Inc.
Orthopedic · 116d
Cleared Sep 03, 2015
Exactech® Novation® Crown Cup®
K141960
Exactech, Inc.
Orthopedic · 412d