Who else makes this device?

Name: Alteon
Brand: Alteon

Alteon · Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer → Orthopedic

10manufacturers in China registered for this device type

7catalogue numbers in this listing

2510(k) clearances naming this product code

3recalls on this code

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (2), 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 KWZ
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
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Xian Airfoil Technology Co., Ltd.	Xian	Shaanxi	Contract manufacturer	8
Lincotek (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	7
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

Record

Regulatory record for Alteon
Listed by	Exactech, Inc., United States
FDA product code	KWZ
Device type	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3310
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K140674
Record published	2022-01-13
Record revised	2023-10-04 (version 3)

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
SPI-040322		In distribution
SPI-045318		In distribution
191-03-15	SZ 15	In distribution
SPI-040324		In distribution
SPI-045312		In distribution
SPI-044833		In distribution
SPI-046561		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
DJO Surgical	Encore Medical, L.P.	159
Instrument	Howmedica Osteonics Corp	139
ZMR®	Zimmer, Inc.	103
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Zimmer, Inc.	69
Arcos Modular Revision System	Biomet Orthopedics	66
Pinnacle	Depuy Orthopaedics, Inc.	52
System 12	Howmedica Osteonics Corp	47
Restoration	Howmedica Osteonics Corp	46
Redapt	Smith & Nephew, Inc.	43
R3	Smith & Nephew, Inc.	41
Trident	Howmedica Osteonics Corp	38
Arcos Modular Revision Hip System	Biomet Orthopedics	37

Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K071676	2007-07-19
K040601	2004-10-04

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

Recalls

3 of these are 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
2023-11-21	Class II	Packaging change control	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
2022-08-11	Class II	Process control	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.	1017 devices
2022-08-11	Class II	Process control	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.	2319 devices

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P960054	1997-06-19	S-ROM POLY-DIAL CONSTRAINED LINER	Depuy, A Johnson & Johnson Co.

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