What is FDA product code OQG?

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.

Dynasty · Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented → Orthopedic

Name: Dynasty
Brand: Dynasty

8manufacturers in China registered for this device type

8catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OQG
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
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
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Shenzhen Fox Hunting E-commerce Co., Ltd.	Shenzhen	Guangdong	Exporter	7

Record

Regulatory record for Dynasty
Listed by	Microport Orthopedics Inc., United States
FDA product code	OQG
Device type	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Device class	Class 2
Regulation	21 CFR 888.3358
Establishment	Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K200011
Record published	2021-10-07

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Dynasty
Catalogue number	Size	Status
DLDMGG46		In distribution
DMNE2842		In distribution
DLDMGH48		In distribution
DLDMGJ54		In distribution
DMNE2856		In distribution
DLDMGC38		In distribution
DMNE2838		In distribution
DMNE2846		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
CS2 Acet. Cup Sys. – VitalitE	Shalby Advanced Technologies, Inc.	169
iTotal® Hip Replacement System	ConforMIS, Inc.	131
CS2 Acet. Cup Sys. – VitalitE	Consensus Orthopedics, Inc.	124
DJO Surgical	Encore Medical, L.P.	99
MobileLink Acetabular Cup System	Waldemar Link GmbH & Co. KG	68
G7	Biomet Orthopedics	54
Vitelene®	Aesculap AG	52
Conformis Hip System	ConforMIS, Inc.	51
Onvoy	Globus Medical, Inc.	48
Ringloc HIP System	Biomet Orthopedics	35
Novosource Total Hip System	Novosource, LLC	33
Prime	Microport Orthopedics Inc.	32

Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K202705	2021-08-20

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.

Dynasty