Who else makes this device?

Name: Arcos Modular Revision Hip System
Brand: Arcos Modular Revision Hip System

Orthopedic › ProstheticProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

Arcos Modular Revision Hip System

40 catalogue numbers from 11-301016, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26

7manufacturers in China registered for this device type

40catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (2), 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 MAY
Manufacturer	City	Province	Registered as	Device types
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
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 Arcos Modular Revision Hip System
Listed by	Biomet Orthopedics, United States
FDA product code	MAY
Device type	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Device class	Class 2
Regulation	21 CFR 888.3353
510(k)	K100469
Record published	2015-10-24
Record revised	2025-05-30 (version 6)

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 Arcos Modular Revision Hip System
Catalogue number	Size	Status
11-301016	16 MM 250 MM	In distribution
11-302148	48 MM	In distribution
11-300625	25 MM 200 MM	In distribution
11-301253	C SIZE 60 MM TYPE 1 TAPER	In distribution
11-300526	26 MM 150 MM	In distribution
11-301918	18 MM 250 MM	In distribution
11-301342	B SIZE 80 MM TYPE I TAPER	In distribution
11-302153	53 MM	In distribution
11-301921	21 MM 250 MM	In distribution
11-302138	38 MM	In distribution
11-300722	22 MM 250 MM	In distribution
11-301225	E SIZE 60 MM TYPE I TAPER	In distribution
11-301024	24 MM 250 MM	In distribution
11-301626	26 MM 200 MM	In distribution
11-302135	35 MM	In distribution
11-301104	D SIZE 60 MM TYPE I TAPER	In distribution
11-302143	43 MM	In distribution
11-300718	18 MM 250 MM	In distribution
11-301231	A SIZE 60 MM TYPE 1 TAPER	In distribution
11-300520	20 MM 150 MM	In distribution
11-301013	13 MM 250 MM	In distribution
11-301243	C SIZE 60 MM TYPE I TAPER	In distribution
11-301313	C SIZE 60 MM TYPE 1 TAPER	In distribution
11-301310	A SIZE 50 MM TYPE 1 TAPER	In distribution
11-300516	16 MM 150 MM	In distribution
11-301521	21 MM 150 MM	In distribution
11-300817	17 MM 150 MM	In distribution
11-302136	36 MM	In distribution
11-302151	51 MM	In distribution
11-300614	14 MM 200 MM	In distribution
11-301324	D SIZE 70 MM TYPE I TAPER	In distribution
11-301623	23 MM 200 MM	In distribution
11-300724	24 MM 250 MM	In distribution
11-300719	19 MM 250 MM	In distribution
11-301214	D SIZE 60 MM TYPE 1 TAPER	In distribution
11-300712	12 MM 250 MM	In distribution
11-301216	F SIZE 60 MM TYPE 1 TAPER	In distribution
11-301205	E SIZE 60 MM TYPE I TAPER	In distribution
11-300916	16 MM 190 MM	In distribution
11-301413	13 MM 115 MM	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Instrument	Howmedica Osteonics Corp	136
Arcos Modular Revision System	Biomet Orthopedics	48
Ringloc HIP System	Biomet Orthopedics	36
Restoration	Howmedica Osteonics Corp	29
Arcos	Biomet Orthopedics	19
Echo® Bi-Metric® Hip System	Biomet Orthopedics	18
Trident	Howmedica Osteonics Corp	12
Arcos® STS™ Modular Revision System	Biomet Orthopedics	10
Ringloc Ranawat / Burstein HIP System	Biomet Orthopedics	10
OrthoMedFlex	Orthomedflex LLC	10
Taperloc Complete Rasp/Provisional	Biomet Orthopedics	9
Regenerex® Ringloc®+ Hip System	Biomet Orthopedics	9

Showing 12 of 40. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

Recalls Naming This Product

3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.

Recalls naming the identifiers of Arcos Modular Revision Hip System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	UDI-DI	2021-06-02	Class II	Process control	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention	81 units	2022-07-06
Biomet, Inc.	UDI-DI	2021-06-02	Class II	Process control	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention	12 units	2022-07-06
Biomet, Inc.	510(k) number	2018-06-08	Class II	Process control	Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.	12	2020-04-14

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.