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 Biomet, Inc., 3M Company and Howmedica Corp..
99
Total
99
Cleared
140d
Avg days
1978
Since
Declining activity -
2 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
234d
recently vs 138d historically
FDA 510(k) Cleared Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented Devices (Product Code KWY)
99 devices
Cleared
Apr 13, 2026
b-ONE® Bipolar Head
B-One Ortho, Corp.
Orthopedic
195d
Cleared
Aug 25, 2025
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
Maxx Orthopedics, Inc.
Orthopedic
273d
Cleared
Dec 19, 2023
CORAIL Cemented Femoral Stem
Depuy Ireland UC
Orthopedic
207d
Cleared
Mar 23, 2023
SpaceFlex Acetabular Cup
G21, S.R.L.
Orthopedic
129d
Cleared
Jul 20, 2022
Vario-Cup System
Waldemar Link GmbH & Co. KG
Orthopedic
29d
Cleared
Mar 23, 2022
COPAL exchange G hip spacer
Heraeus Medical GmbH
Orthopedic
29d
Cleared
Apr 17, 2020
Kyocera Bipolar Hip System
Kyocera Medical Technologies, Inc.
Orthopedic
30d
Cleared
Nov 05, 2019
Fitmore Hip Stem
Zimmer GmbH
Orthopedic
78d
Cleared
Nov 01, 2019
COPAL exchange G Hip and Knee Spacers
Heraeus Medical GmbH
Orthopedic
198d
Cleared
Sep 17, 2019
iNSitu Bipolar Hip System
Theken Companies, LLC
Orthopedic
126d
Cleared
Aug 28, 2019
Implantcast ic-Bipolar Head System
Implantcast GmbH
Orthopedic
76d
Cleared
Jun 05, 2019
Corin BiPolar-i
Corin U.S.A. Limited
Orthopedic
208d
Cleared
Jun 14, 2018
SurgTech Bipolar Head System
Surgtech, Inc.
Orthopedic
219d
Cleared
Feb 23, 2018
ELEOS™ Bipolar Acetabular System
Onkos Surgical, Inc.
Orthopedic
37d
Cleared
Jan 29, 2018
40-42mm BiPolar Head and 22mm Femoral Head
Signature Orthopaedics Pty, Ltd.
Orthopedic
452d
Cleared
Sep 29, 2006
GLADIATOR BIPOLAR SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
18d
Cleared
May 31, 2006
AESCULAP BIPOLAR ACETABULAR CUP
Aesculap, Inc.
Orthopedic
76d
Cleared
Dec 16, 2005
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
Biomet, Inc.
Orthopedic
53d
Cleared
Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
Smith & Nephew, Inc.
Orthopedic
77d
Cleared
Dec 15, 2000
M2A 32MM TAPER SYSTEM
Biomet, Inc.
Orthopedic
49d
Cleared
Sep 10, 1999
TRI-POLAR SYSTEM
Biomet, Inc.
Orthopedic
88d
Cleared
Dec 16, 1996
ADVANTAGE MAPF HIP FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
306d
Cleared
Sep 18, 1995
UHMWPE COMPONENTS-CHANGE IN PACKAGING
Depuy, Inc.
Orthopedic
579d
Cleared
Mar 01, 1994
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
Howmedica Corp.
Orthopedic
504d
About Product Code KWY - Regulatory Context
510(k) Submission Activity
99 total 510(k) submissions under product code KWY since 1978, with 99 receiving FDA clearance (average review time: 140 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - KWY Product Code
Recent submissions under KWY have taken an average of 234 days to reach a decision - up from 138 days historically. Manufacturers should account for longer review timelines in current project planning.
KWY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →