Who else makes this device?

Name: Alteon
Brand: Alteon

Alteon · Prosthesis, Hip, Hemi-, Femoral, Metal → Orthopedic

10manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWL
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Xian Airfoil Technology Co., Ltd.	Xian	Shaanxi	Contract manufacturer	8
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
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 Alteon
Listed by	Exactech, Inc., United States
FDA product code	KWL
Device type	Prosthesis, Hip, Hemi-, Femoral, Metal
Device class	Class 2
Regulation	21 CFR 888.3360
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K162732
Record published	2022-08-18

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Alteon
Catalogue number	Size	Status
191-03-04	SZ 4	In distribution
191-03-07	SZ 7	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ustar II Knee System	United Orthopedic Corp.	115
Consensus Hip System	Shalby Advanced Technologies, Inc.	95
Consensus® Hip System	Consensus Orthopedics, Inc.	95
Instrument	Howmedica Osteonics Corp	94
UHR	Howmedica Osteonics Corp	75
Austin Moore	Howmedica Osteonics Corp	67
B-P Total HIP System	Endotec, Inc.	66
CS2 Acetabular Cup System	Consensus Orthopedics, Inc.	64
DJO Surgical	Encore Medical, L.P.	62
Restoration	Howmedica Osteonics Corp	56
Optimom Modular Heads	Corin Limited	49
Corin Unipolar Modular Head	Corin Limited	36

Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K031841	2004-01-22
K960538	1996-03-27

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 Alteon
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Exactech, Inc.	510(k) number	2017-10-09	Class II	Error in labeling	Wrong device description of the label identifying the implant	34	2019-08-06

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.

Alteon