Who else makes this device?

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

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

10manufacturers in China registered for this device type

37catalogue 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 Hip 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)	K090757
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
11-300924	24 MM 190 MM	In distribution
11-300923	23 MM 190 MM	In distribution
11-300513	13 MM 150 MM	In distribution
11-301726	26 MM 250 MM	In distribution
11-300721	21 MM 250 MM	In distribution
11-302149	49 MM	In distribution
11-301113	C SIZE 60 MM TYPE 1 TAPER	In distribution
11-300616	16 MM 200 MM	In distribution
11-301612	12 MM 200 MM	In distribution
11-302026	26 MM 300 MM	In distribution
11-301315	E SIZE 60 MM TYPE 1 TAPER	In distribution
11-301115	E SIZE 60 MM TYPE 1 TAPER	In distribution
11-301355	E SIZE 80 MM TYPE 1 TAPER	In distribution
11-301241	A SIZE 60 MM TYPE I TAPER	In distribution
11-302134	34 MM	In distribution
11-300920	20 MM 190 MM	In distribution
11-300512	12 MM 150 MM	In distribution
11-300822	22 MM 150 MM	In distribution
11-300829	29 MM 150 MM	In distribution
11-301116	F SIZE 60 MM TYPE 1 TAPER	In distribution
11-301816	16 MM 200 MM	In distribution
11-301244	D SIZE 60 MM TYPE I TAPER	In distribution
11-301352	B SIZE 80 MM TYPE 1 TAPER	In distribution
11-300518	18 MM 150 MM	In distribution
11-301223	C SIZE 60 MM TYPE I TAPER	In distribution
11-301019	19 MM 250 MM	In distribution
11-301112	B SIZE 60 MM TYPE 1 TAPER	In distribution
11-301614	14 MM 200 MM	In distribution
11-301303	C SIZE 60 MM TYPE I TAPER	In distribution
11-301252	B SIZE 60 MM TYPE 1 TAPER	In distribution
11-301306	F SIZE 60 MM TYPE I TAPER	In distribution
11-300828	28 MM 150 MM	In distribution
11-300825	25 MM 150 MM	In distribution
11-301206	F SIZE 60 MM TYPE I TAPER	In distribution
11-300922	22 MM 190 MM	In distribution
11-302146	46 MM	In distribution
11-300717	17 MM 250 MM	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
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

2 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	7 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

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 Hip System