KWY · Class II · 21 CFR 888.3390

FDA Product Code KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

Hip hemiarthroplasty is the standard treatment for femoral neck fractures in elderly patients. FDA product code KWY covers cemented femoral hip hemiarthroplasty prostheses.

These cemented implants replace only the femoral head — leaving the native acetabulum intact — to restore hip mobility and relieve pain following femoral neck fractures without the complexity of total hip replacement in frail patients.

KWY devices are Class II medical devices, regulated under 21 CFR 888.3390 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Johnson & Johnson Professionals, Inc., Biomet, Inc. and Ortho Development Corp..

99
Total
99
Cleared
140d
Avg days
1978
Since
99 devices
25–48 of 99
Cleared Oct 08, 2010
UNITED U2 BIPOLAR IMPLANT
K101670
United Orthopedic Corp.
Orthopedic · 116d
Cleared Mar 02, 2010
MEDACTA BIPOLAR HEAD
K091967
Medacta International S.A.
Orthopedic · 244d
Cleared Feb 18, 2009
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
K082468
Omni Life Science, Inc.
Orthopedic · 175d
Cleared Dec 15, 2008
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
K082705
Biopro, Inc.
Orthopedic · 90d
Cleared Oct 31, 2008
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
K080979
Biomet Manufacturing Corp
Orthopedic · 207d
Cleared Sep 29, 2006
GLADIATOR BIPOLAR SYSTEM
K062693
Wrightmedicaltechnologyinc
Orthopedic · 18d
Cleared May 31, 2006
AESCULAP BIPOLAR ACETABULAR CUP
K060707
Aesculap, Inc.
Orthopedic · 76d
Cleared Dec 16, 2005
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
K052990
Biomet, Inc.
Orthopedic · 53d
Cleared Aug 29, 2005
U1 HIP SYSTEM - BIPOLAR
K050269
United Orthopedic Corp.
Orthopedic · 206d
Cleared Jul 07, 2005
PIVOT BIPOLAR FEMORAL HEAD
K050966
Ortho Development Corp.
Orthopedic · 80d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Mar 08, 2002
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
K014072
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 88d
Cleared Dec 05, 2001
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211
Exactech, Inc.
Orthopedic · 70d
Cleared Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081
Exactech, Inc.
Orthopedic · 26d
Cleared Dec 15, 2000
M2A 32MM TAPER SYSTEM
K003363
Biomet, Inc.
Orthopedic · 49d
Cleared Sep 10, 1999
TRI-POLAR SYSTEM
K991990
Biomet, Inc.
Orthopedic · 88d
Cleared Dec 04, 1998
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812
Johnson & Johnson Professionals, Inc.
Orthopedic · 115d
Cleared Nov 25, 1998
PLUS BIPOLAR PROSTHESIS COCRMO
K982447
Plus Orthopedics
Orthopedic · 133d
Cleared Oct 07, 1998
ODC B2 BIPOLAR CUP
K982389
Ortho Development Corp.
Orthopedic · 90d
Cleared Aug 21, 1998
BIPOLAR FEMORAL HEAD
K981238
Whiteside Biomechanics, Inc.
Orthopedic · 140d
Cleared May 29, 1998
J-FX BIPOLAR HEAD
K980801
Johnson & Johnson Professionals, Inc.
Orthopedic · 88d
Cleared Apr 30, 1997
IMPLEX BIPOLAR HIP SYSTEM
K970447
Implex Corp.
Orthopedic · 83d
Cleared Apr 21, 1997
ARTOS, DIPLOS SYSTEM
K970284
Turnkey Intergration USA, Inc.
Orthopedic · 87d
Cleared Dec 16, 1996
ADVANTAGE MAPF HIP FEMORAL COMPONENT
K960643
Biomet, Inc.
Orthopedic · 306d