Who else makes this device?

Name: StageOne Select
Brand: StageOne Select

Orthopedic › ProstheticProsthesis, Hip, Hemi-, Femoral, Metal

StageOne Select

14 catalogue numbers from 431187, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26

10manufacturers in China registered for this device type

14catalogue numbers in this listing

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 StageOne Select
Listed by	Biomet Orthopedics, United States
FDA product code	KWL
Device type	Prosthesis, Hip, Hemi-, Femoral, Metal
Device class	Class 2
Regulation	21 CFR 888.3360
510(k)	K080979
Record published	2015-10-24
Record revised	2025-05-30 (version 8)

Specifications

Specifications
MRI safety	MR Unsafe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for StageOne Select
Catalogue number	Size	Status
431187	+6 mm	In distribution
431185	64 mm	In distribution
431190	9 mm 125 mm	In distribution
431194	17 mm 165 mm	In distribution
431191	11 mm 135 mm	In distribution
431198	15 mm 200 mm	In distribution
431190	9 mm 125 mm	In distribution
431192	13 mm 145 mm	In distribution
431195	9 mm 200 mm	In distribution
431181	48 mm	In distribution
431197	13 mm 200 mm	In distribution
431194	17 mm 165 mm	In distribution
431182	52 mm	In distribution
431186	Standard Size	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

Recalls Naming This Product

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

Recalls naming the identifiers of StageOne Select
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230, 001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230, 001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29
Biomet, Inc.	510(k) number	2020-02-26	Class II	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.	230,001	2021-07-29

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.