Who else makes this device?

Name: StageOne Select
Brand: StageOne Select

Orthopedic › ProstheticBone Cement, Antibiotic

StageOne Select

3 catalogue numbers from 431193, listed by Biomet Orthopedics, United States, under Bone Cement, Antibiotic. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code MBB
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for StageOne Select
Listed by	Biomet Orthopedics, United States
FDA product code	MBB
Device type	Bone Cement, Antibiotic
Device class	Class 2
Regulation	21 CFR 888.3027
510(k)	K080979
Record published	2026-03-17

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
431193	15 mm 155 mm	In distribution
431198	15 mm 200 mm	In distribution
431199	17 MM 200 MM	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Remedy Spacer	Osteoremedies, LLC	28
CeMend Shoulder Spacer Mold	G21 SRL	12
Palacos®	Heraeus Medical LLC	8
StageOne™	Biomet Orthopedics	8
SpaceFlex Shoulder	G21 SRL	6
Interspace Tapered Wedge Stem	Tecres SPA	6
InterSpace Hip	Tecres SPA	6
Surespace	Ortho Development Corp.	5
Prostalac	Depuy Orthopaedics, Inc.	4
CeMend Shoulder Spacer	G21 SRL	4
Rally	Smith & Nephew, Inc.	3
Smartset	Depuy (Ireland)	3

Showing 12 of 44. All products under Bone Cement, Antibiotic

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.