Who else makes this device?

Name: CSB
Brand: CSB

CSB · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented → Orthopedic

6manufacturers in China registered for this device type

2catalogue numbers in this listing

4510(k) clearances naming this product code

5recalls on this code

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KWT
Manufacturer	City	Province	Registered as	Device types
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for CSB
Listed by	Exactech, Inc., United States
FDA product code	KWT
Device type	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class	Class 2
Regulation	21 CFR 888.3650
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K233482
Record published	2026-01-28

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for CSB
Catalogue number	Size	Status
321-52-68	0°	In distribution
321-52-69	8°, 10°, 8°/10°	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Equinoxe	Exactech, Inc.	336
SMR Shoulder	Limacorporate	289
Tornier Perform Humeral System	Tornier Inc.	119
Bigliani/Flatow®	Zimmer, Inc.	119
Trabecular Metal®	Zimmer, Inc.	115
Jarvis Glenoid Rerverse Shoulder Prosthesis	Fournitures Hospitalieres Industrie	103
Comprehensive® Shoulder System	Biomet Orthopedics	86
Alliance®	Zimmer, Inc.	68
Anatomical Shoulder™	Zimmer, Inc.	54
Aetos Shoulder System	Smith & Nephew, Inc.	53
Perform™ Humeral System	Tornier Inc.	47
Bio-Modular® Shoulder System	Biomet Orthopedics	43

Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250713	2025-12-01
K162903	2017-02-27
K143659	2015-04-09
K110706	2011-05-17

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2023-11-21	Class II	Packaging change control	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
2018-08-21	Class II	Under Investigation by firm	The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.	2 units
2016-10-25	Class II	Component design/selection	Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.	2,278 units	2019-07-26
2012-06-15	Class II	Labeling False and Misleading	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that th	54,877 units for all products in Recall Event	2013-07-03
2012-06-15	Class II	Labeling False and Misleading	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that th	54,877 units for all products in Recall Event	2013-07-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

CSB