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
Cleared
Nov 21, 2017
Smith & Nephew, Inc. REDAPT Augments
Smith & Nephew, Inc.
Orthopedic
224d
Cleared
Oct 24, 2017
UTS Stem
United Orthopedic Corporation
Orthopedic
90d
Cleared
Oct 17, 2017
Bencox Mirabo Cup System
Corentec Co., Ltd.
Orthopedic
29d
Cleared
Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
Smith & Nephew, Inc.
Orthopedic
27d
Cleared
Oct 02, 2017
Trident® II Acetabular System
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic
110d
Cleared
Sep 21, 2017
iNSitu Total Hip System
Theken Companies, LLC
Orthopedic
34d
Cleared
Jul 24, 2017
Klassic HD® Hip System
Total Joint Othopedics, Inc.
Orthopedic
24d
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
Dec 05, 2016
Bencox M Stem Lateralized & Bencox Mirabo Cup System
Corentec Co., Ltd.
Orthopedic
126d
Cleared
Oct 19, 2016
Klassic HD Hip System
Total Joint Othopedics, Inc.
Orthopedic
184d
Cleared
Oct 14, 2016
iNSitu Total Hip System
Theken Companies, LLC
Orthopedic
170d
Cleared
Oct 14, 2016
Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic
129d
Cleared
Jul 27, 2016
The Progressive Orthopaedic Total Hip System
The Progressive Orthopaedic Company, LLC
Orthopedic
426d
Cleared
May 26, 2016
G7 Dual Mobility System, Active Articulation System
Biomet, Inc.
Orthopedic
29d
Cleared
May 25, 2016
Stryker Orthopaedics Hip Systems Labeling Update
Stryker Orthopaedics
Orthopedic
188d
Cleared
May 17, 2016
Escalade Legend Acetabular Shell
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
Corentec Co., Ltd.
Orthopedic
277d
Cleared
Apr 08, 2016
ICONACY(TM) I-Hip(TM)
Iconacy Orthopedic Implants, LLC
Orthopedic
66d
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