FDA Product Code KWT: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Under FDA product code KWT, non-constrained shoulder prostheses with metal and polymer bearing surfaces are cleared for shoulder hemiarthroplasty and total arthroplasty.
Non-constrained designs rely on intact rotator cuff function and soft tissue balance for joint stability rather than mechanical constraint. They are indicated in patients with preserved rotator cuff integrity and normal glenoid bone stock.
KWT devices are Class II medical devices, regulated under 21 CFR 888.3650 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Biomet, Inc., Zimmer, Inc. and Catalyst Orthoscience, Inc..
71
Total
71
Cleared
131d
Avg days
1979
Since
Growing category -
4 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
225d
recently vs 126d historically
FDA 510(k) Cleared Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented Devices (Product Code KWT)
71 devices
Cleared
Dec 01, 2025
Equinoxe® Humeral Reconstruction Prosthesis
Exactech, Inc.
Orthopedic
266d
Cleared
Oct 30, 2025
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
Tornier, Inc.
Orthopedic
150d
Cleared
Mar 10, 2025
AGILON® XO Shoulder Replacement System
Implantcast GmbH
Orthopedic
251d
Cleared
Feb 11, 2025
InSet Total Shoulder System
Shoulder Innovations, Inc.
Orthopedic
232d
Cleared
Feb 16, 2024
AGILON® XO Shoulder Replacement System
Implantcast GmbH
Orthopedic
254d
Cleared
Jul 12, 2023
Comprehensive Segmental Revision System(SRS)
Biomet Orthopedics
Orthopedic
219d
Cleared
Sep 28, 2022
AGILON XO Shoulder System
Implantcast GmbH
Orthopedic
42d
Cleared
Jun 21, 2021
LINK Embrace Shoulder System- Anatomical Configuration
Waldemar Link GmbH & Co. KG
Orthopedic
87d
Cleared
Jul 16, 2020
TiN Coated Humeral Head
Fx Shoulder USA, Inc.
Orthopedic
387d
Cleared
Nov 29, 2019
Shoulder Innovations Total Shoulder System
Shoulder Innovations, Inc.
Orthopedic
91d
Cleared
Sep 11, 2019
Catalyst OrthoScience CSR Shoulder System
Catalyst Orthoscience, Inc.
Orthopedic
68d
Cleared
Jun 05, 2019
Signature ONE System
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic
90d
Cleared
Jan 11, 2019
Catalyst CSR Press-Fit Humeral Components
Catalyst Orthoscience, Inc.
Orthopedic
121d
Cleared
Jul 12, 2018
Catalyst CSR Shoulder System
Catalyst Orthoscience, Inc.
Orthopedic
57d
Cleared
Mar 09, 2018
Catalyst CSR 3 Peg Glenoids
Catalyst Orthoscience, Inc.
Orthopedic
84d
Cleared
Feb 27, 2017
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Exactech, Inc.
Orthopedic
133d
Cleared
Oct 11, 2012
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
Zimmer, Inc.
Orthopedic
139d
Cleared
Dec 15, 2011
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
Biomet, Inc.
Orthopedic
177d
Cleared
Sep 02, 2011
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
Zimmer, Inc.
Orthopedic
165d
Cleared
Apr 11, 2005
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
Zimmer, Inc.
Orthopedic
18d
Cleared
Feb 09, 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
Biomet, Inc.
Orthopedic
51d
Cleared
Sep 01, 2004
ZIMMER TRABECULAR METAL HUMERAL STEM
Zimmer, Inc.
Orthopedic
84d
Cleared
Sep 05, 2003
INTERLOK BIO-MODULAR HUMERAL STEMS
Biomet, Inc.
Orthopedic
22d
Cleared
Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
Biomet, Inc.
Orthopedic
90d
About Product Code KWT - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code KWT since 1979, with 71 receiving FDA clearance (average review time: 131 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - KWT Product Code
Recent submissions under KWT have taken an average of 225 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.
KWT devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →