Who else makes this device?

Name: TiN Coated Glenosphere
Brand: TiN Coated Glenosphere

TiN Coated Glenosphere · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented → Orthopedic

6manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product 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 TiN Coated Glenosphere
Listed by	Fx Solutions, France
FDA product code	KWT
Device type	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class	Class 2
Regulation	21 CFR 888.3650
510(k)	K191146
Record published	2024-01-22

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for TiN Coated Glenosphere
Catalogue number	Size	Status
115-3211		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
K140071	2014-07-28
K123814	2013-08-13

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of TiN Coated Glenosphere
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Fx Shoulder Solutions SAS	510(k) number	2023-08-08	Class II	Labeling mix-ups	Centered glenosphere box may contain an eccentric glenosphere.	4

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.

TiN Coated Glenosphere