What is FDA product code OQI?

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

U-Motion II™ · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented → Orthopedic

Name: U-Motion II™
Brand: U-Motion II™

5manufacturers in China registered for this device type

5catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OQI
Manufacturer	City	Province	Registered as	Device types
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
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 U-Motion II™
Listed by	United Orthopedic Corp., Taiwan
FDA product code	OQI
Device type	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Device class	Class 2
Regulation	21 CFR 888.3353
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K122185
Record published	2017-05-19
Record revised	2020-12-21 (version 9)

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
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for U-Motion II™
Catalogue number	Size	Status
1406-4250	ID32mm, OD50mm	In distribution
1406-6662	20°, ID36mm, OD62mm,	In distribution
1306-2045		In distribution
1406-4058	ID40mm, OD58mm	In distribution
1306-2045		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Kyocera Medical Technologies, Inc.	Kyocera Medical Technologies, Inc.	260
Epore® XO	implantcast GmbH	64
G7®	Biomet Orthopedics	50
InSitu Hip System	Nextstep Arthropedix	50
G7 Acetabular Liner	Biomet Orthopedics	47
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	implantcast GmbH	40
Novation	Exactech, Inc.	37
Trinity Acetabular Hip System with ECiMa Liners	Corin Limited	28
Procotyl® Prime	Microport Orthopedics Inc.	25
AcuMatch	Exactech, Inc.	23
Continuum® Trilogy® Allofit®	Zimmer, Inc.	23
G7® Longevity®	Zimmer, Inc.	23

Showing 12 of 164. All products under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K172833	2018-06-12

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.

U-Motion II™