Who else makes this device?

Name: Integral Centralizer HIP System
Brand: Integral Centralizer HIP System

Orthopedic › ProstheticProsthesis, Hip, Femoral Component, Cemented, Metal

Integral Centralizer HIP System

4 catalogue numbers from 11-162717, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

4catalogue numbers in this listing

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 Integral Centralizer HIP System
Listed by	Biomet Orthopedics, United States
FDA product code	JDG
Device type	Prosthesis, Hip, Femoral Component, Cemented, Metal
Device class	Class 2
Regulation	21 CFR 888.3360
510(k)	K942479
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 Integral Centralizer HIP System
Catalogue number	Size	Status
11-162717	17 SIZE 165 MM TYPE1 TAPER	In distribution
11-162715	15 SIZE 155 MM TYPE1 TAPER	In distribution
11-162709	9 SIZE 125 MM TYPE1 TAPER	In distribution
12-162617	17 SIZE 165 MM TYPE1 TAPER	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

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

Recalls naming the identifiers of Integral Centralizer HIP System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2015-11-17	Class II	Labeling Change Control	PMMA is listed as a material on the label but the product does not contain PMMA.	21	2016-07-05

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.