Who else makes this device?

Name: Copeland EAS Shoulder System
Brand: Copeland EAS Shoulder System

Orthopedic › ProstheticProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Copeland EAS Shoulder System

2 catalogue numbers from 11-114661, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.

Registry build 21.09.26

6manufacturers in China registered for this device type

2catalogue numbers in this listing

3510(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 Copeland EAS Shoulder System
Listed by	Biomet Orthopedics, United States
FDA product code	KWT
Device type	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class	Class 2
Regulation	21 CFR 888.3650
510(k)	K051843
Record published	2015-10-24
Record revised	2025-05-30 (version 4)

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 Copeland EAS Shoulder System
Catalogue number	Size	Status
11-114661	SIZE 1	In distribution
11-114663	SIZE 3	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
K223631	2023-07-12
K023063	2002-12-13
K020045	2002-01-30

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 Copeland EAS Shoulder System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2019-08-21	Class II	Environmental control	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.	219988 units (total)	2021-07-21

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.