Who else makes this device?

Name: Ringloc RX90-2 HIP System
Brand: Ringloc RX90-2 HIP System

Orthopedic › ProstheticProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Ringloc RX90-2 HIP System

26 catalogue numbers from 11-105963, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26

10manufacturers in China registered for this device type

26catalogue 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 Ringloc RX90-2 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)	K042989
Record published	2015-10-24
Record revised	2025-05-30 (version 4)

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 Ringloc RX90-2 HIP System
Catalogue number	Size	Status
11-105963	32MM HEAD SIZE 43 LINER SIZE	In distribution
11-105973	32MM HEAD SIZE 43 LINER SIZE	In distribution
11-105967	32MM HEAD SIZE 47 LINER SIZE	In distribution
XL-129072	32MM HEAD SIZE 42 LINER SIZE	In distribution
11-105977	32mm Head Size 47 Liner Size	In distribution
11-105968	32MM HEAD SIZE 48 LINER SIZE	In distribution
11-105954	28MM HEAD SIZE 44 LINER SIZE	In distribution
XL-129052	28MM HEAD SIZE 42 LINER SIZE	In distribution
11-105964	32mm Head Size 44 Liner Size	In distribution
XL-104947	28mm Head Size 47 Liner Size	In distribution
11-105974	32MM HEAD SIZE 44 LINER SIZE	In distribution
12-105933	28MM HEAD SIZE 43 LINER SIZE	In distribution
12-105938	28MM HEAD SIZE 48 LINER SIZE	In distribution
11-105946	28MM HEAD SIZE 46 LINER SIZE	In distribution
XL-106954	28mm Head Size 44 Liner Size	In distribution
11-105953	28mm Head Size 43 Liner Size	In distribution
11-105975	32mm Head Size 45 Liner Size	In distribution
XL-104943	28MM HEAD SIZE 43 LINER SIZE	In distribution
10-129057	28MM HEAD SIZE 47 LINER SIZE	In distribution
11-105944	28mm Head Size 44 Liner Size	In distribution
XL-129055	28mm Head Size 45 Liner Size	In distribution
11-105958	28MM HEAD SIZE 48 LINER SIZE	In distribution
12-105946	32MM HEAD SIZE 46 LINER SIZE	In distribution
XL-129078	32MM HEAD SIZE 48 LINER SIZE	In distribution
XL-104941	28MM HEAD SIZE 41 LINER SIZE	In distribution
11-105958	28mm Head Size 48 Liner Size	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
Arcos Modular Revision Hip System	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 Ringloc RX90-2 HIP System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2017-02-17	Class II	Process design	Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.	28,253 in total	2018-01-29

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.