Who else makes this device?

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

Arcos Modular Revision System · Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer → Orthopedic

10manufacturers in China registered for this device type

66catalogue numbers in this listing

1510(k) clearance

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 Arcos Modular Revision System
Listed by	Biomet Orthopedics, 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
510(k)	K100469
Record published	2016-10-28
Record revised	2025-05-30 (version 8)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for Arcos Modular Revision System
Catalogue number	Size	Status
31-301109	LARGE	In distribution
31-301346	80 mm Size F	In distribution
31-301852	3.5 MM	In distribution
31-301321	70 mm Size A	In distribution
31-301806	9.5MM	In distribution
31-301337	SIZE G 70MM HIGH OFFSET	In distribution
31-301817	15MM	In distribution
31-301362	SIZE B	In distribution
31-301624	24 mm X 200 mm	In distribution
31-301815	14MM	In distribution
31-301526	26 mm X 150 mm	In distribution
31-301343	SIZE C 80MM STANDARD OFFSET	In distribution
31-301357	80 mm Size G	In distribution
31-302024	24 mm X 300 mm	In distribution
31-301622	22MM X 200MM	In distribution
31-301722	22 mm X 250 mm	In distribution
31-301726	26 mm X 250 mm	In distribution
31-301324	70 mm Size D	In distribution
31-301515	15MM X 150MM	In distribution
31-301810	11.5 mm	In distribution
31-311343	Size C / 80 mm /	In distribution
31-301356	SIZE F 80MM HIGH OFFSET	In distribution
31-300830	30MM X 150MM	In distribution
31-301829	21 mm	In distribution
31-311354	Size D / 80 mm /	In distribution
31-301622	22 mm X 200 mm	In distribution
31-301305	SIZE E 60MM STANDARD OFFSET	In distribution
31-301626	26 mm X 200 mm	In distribution
31-301106	60 mm Size F	In distribution
31-301323	SIZE C 70MM STANDARD OFFSET	In distribution
31-301809	11 mm	In distribution
31-301524	24 mm X 150 mm	In distribution
31-300572	Size 22	In distribution
31-300563	Size 13	In distribution
31-301618	18 mm X 200 mm	In distribution
31-301860	300 INCH-POUNDS	In distribution
31-301345	SIZE E 80MM STANDARD OFFSET	In distribution
31-301306	Size F 60 mm	In distribution
31-300976	26MM X 190MM	In distribution
31-300967	17MM X 190MM	In distribution
31-301421	21MM X 115MM	In distribution
31-301854		In distribution
31-300964	14MM X 190MM	In distribution
31-311336	SIZE F 70MM HIGH OFFSET	In distribution
31-301352	SIZE B 80MM HIGH OFFSET	In distribution
31-301200	50 mm Size A	In distribution
31-301841	27 mm	In distribution
110018390	SIZE C	In distribution
31-301333	SIZE C 70MM HIGH OFFSET	In distribution
31-301718	18 mm X 250 mm	In distribution
31-301333	70 mm Size C	In distribution
31-301525	25MM X 150MM	In distribution
31-301364	SIZE D	In distribution
31-301304	60 mm Size D	In distribution
31-301826	19.5MM	In distribution
31-301812	12.5 mm	In distribution
31-301368		In distribution
31-300862	12MM X 150/250MM	In distribution
31-301310	50 mm Size A	In distribution
31-301821	17MM	In distribution
31-301818	15.5MM	In distribution
31-311301	Size A / 60 mm /	In distribution
31-301818	15.5 mm	In distribution
31-300573	SIZE 23	In distribution
31-301422	22MM X 115MM	In distribution
31-301000		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
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
G7®	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
K021661	2002-10-25

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 Arcos Modular Revision System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
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

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.

Arcos Modular Revision System