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.

Orthopedic › ProstheticHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

M2A Magnum HIP System

Name: M2A Magnum HIP System
Brand: M2A Magnum HIP System

13 catalogue numbers from US257850, listed by Biomet Orthopedics, United States, under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26

8manufacturers in China registered for this device type

13catalogue numbers in this listing

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 M2A Magnum HIP System
Listed by	Biomet Orthopedics, 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
510(k)	K101336
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
Distribution end date	2015-10-24

Catalogue Numbers

Catalogue numbers for M2A Magnum HIP System
Catalogue number	Size	Status
US257850	50MM OUTER Ø 44MM INNER Ø	In distribution
US257846	46MM OUTER Ø 40MM INNER Ø	In distribution
US157844	44MM OUTER Ø 38MM INNER Ø	In distribution
US257864	64MM OUTER Ø 58MM INNER Ø	In distribution
US157848	48MM OUTER Ø 42MM INNER Ø	In distribution
US157844	44MM OUTER Ø 38MM INNER Ø	In distribution
US157862	62MM OUTER Ø 56MM INNER Ø	In distribution
US257852	52MM OUTER Ø 46MM INNER Ø	In distribution
US257864	64MM OUTER Ø 58MM INNER Ø	In distribution
US157866	66MM OUTER Ø 60MM INNER Ø	In distribution
139259	42-50MM HEAD SIZE Ø TYPE I TAPER	Withdrawn
139256	42-50MM HEAD SIZE Ø TYPE I TAPER	Withdrawn
139272	52-60MM HEAD SIZE Ø TYPE I TAPER	Withdrawn

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

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 M2A Magnum HIP System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2013-04-26	Class II	Labeling mix-ups	Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrec	8 units	2013-08-29

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.