Who else makes this device?

Name: Prosthesis Head Large
Brand: Prosthesis Head Large

Prosthesis Head Large · Prosthesis, Hip, Femoral Component, Cemented, Metal → Orthopedic

5manufacturers in China registered for this device type

6catalogue numbers in this listing

6recalls on this code

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDG
Manufacturer	City	Province	Registered as	Device types
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54

Record

Regulatory record for Prosthesis Head Large
Listed by	Waldemar Link GmbH & Co. KG, Germany
FDA product code	JDG
Device type	Prosthesis, Hip, Femoral Component, Cemented, Metal
Device class	Class 2
Regulation	21 CFR 888.3360
Establishment	Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K953653
Record published	2015-11-01
Record revised	2020-04-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	expiry date, serial number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Prosthesis Head Large
Catalogue number	Size	Status
99-0711/58		In distribution
99-0711/50		In distribution
99-0710/54		In distribution
99-0710/50		In distribution
99-0711/54		In distribution
99-0710/58		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
R3	Smith & Nephew, Inc.	554
Emperion	Smith & Nephew, Inc.	262
Reflection	Smith & Nephew, Inc.	253
Spii Model Lubinus	Waldemar Link GmbH & Co. KG	174
Polar	Smith & Nephew, Inc.	132
Anthology	Smith & Nephew, Inc.	129
Echelon	Smith & Nephew, Inc.	122
Synergy	Smith & Nephew, Inc.	102
Prosthesis, Hip, Femoral Component, Cemented, Metal	Smith & Nephew, Inc.	93
Trigen	Smith & Nephew, Inc.	66
Prosthesis Head B	Waldemar Link GmbH & Co. KG	62
Corin Taper-Fit Total Hip System	Corin Limited	55

Showing 12 of 71. All products under Prosthesis, Hip, Femoral Component, Cemented, Metal

Recalls Naming This Product

5 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Prosthesis Head Large
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Waldemar Link GmbH & Co. KG	510(k) number	2025-07-15	Class II	Under Investigation by firm	Inconsistent size terminology and color coding used on labeling	46 units
Waldemar Link GmbH & Co. KG	510(k) number	2024-02-06	Class II	Under Investigation by firm	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.	382 units
Waldemar Link GmbH & Co. KG	510(k) number	2024-02-06	Class II	Under Investigation by firm	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.	34 units
Waldemar Link GmbH & Co. KG	510(k) number	2024-02-06	Class II	Under Investigation by firm	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.	153 Units
Waldemar Link GmbH & Co. KG	510(k) number	2024-02-06	Class II	Under Investigation by firm	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.	0 units

Recalls

1 of these is 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
2025-07-15	Class II	Under Investigation by firm	Inconsistent size terminology and color coding used on labeling	17 units

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.

Prosthesis Head Large