Who else makes this device?

Name: Biomet® Hip System
Brand: Biomet® Hip System

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

Biomet® Hip System

4 catalogue numbers from 163660, 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 Biomet® 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)	K911684
Record published	2019-04-18
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 Biomet® Hip System
Catalogue number	Size	Status
163660	28mm Ø Type1 Taper	In distribution
163668	32mm Ø Type1 Taper	In distribution
163666	28mm Ø Type1 Taper	In distribution
163663	28mm Ø 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

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

Recalls naming the identifiers of Biomet® Hip System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2020-11-25	Class II	Process control	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.	7428	2024-05-08
Biomet, Inc.	510(k) number	2018-04-02	Class II	Nonconforming Material/Component	Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.	30	2020-05-12
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
Biomet, Inc.	510(k) number	2015-04-16	Class III	Labeling mix-ups	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.	1315	2016-05-16
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	16	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	5	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	12	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	33	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	30	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	28	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	16	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	25	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	35	2003-09-23
Biomet, Inc.	510(k) number	2003-06-18	Not classified	Other	The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.	31	2003-09-23

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.