What is FDA product code OQH?

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, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

Sirius® Hip System

Name: Sirius® Hip System
Brand: Sirius® Hip System

3 catalogue numbers from 51-199351, listed by Biomet Orthopedics, United States, under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

3catalogue numbers in this listing

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 OQH
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 Sirius® Hip System
Listed by	Biomet Orthopedics, United States
FDA product code	OQH
Device type	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
Device class	Class 2
Regulation	21 CFR 888.3350
510(k)	K130610
Record published	2018-08-15
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 Sirius® Hip System
Catalogue number	Size	Status
51-199351	50F Size Type1 Taper	In distribution
51-199342	44E SIZE TYPE1 TAPER	In distribution
51-199334	34C SIZE TYPE1 TAPER	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
G7®	Biomet Orthopedics	61
G7 Acetabular Liner	Biomet Orthopedics	41
G7® Longevity®	Zimmer, Inc.	20
Restoris Xlve	Mako Surgical Corp.	20
Continuum® Trilogy® Allofit®	Zimmer, Inc.	17
Arcos® One-piece Revision System	Biomet Orthopedics	16
G7® Vivacit-E®	Zimmer, Inc.	15
RingLoc Hip System	Biomet Orthopedics	15
Continuum® Trilogy® Allofit® Vivacit-E®	Zimmer, Inc.	14
Restoris	Mako Surgical Corp.	12
G7® Acetabular System	Biomet Orthopedics	11
Sirius	Biomet Orthopedics	7

Showing 12 of 42. All products under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Sirius® Hip System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2014-12-02	Class II	Mixed-up of materials/components	After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 34B Catalog Number: 51-199333, Lot Number	9	2015-10-27
Biomet, Inc.	510(k) number	2014-12-02	Class II	Mixed-up of materials/components	After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 348 Catalog Number: 51-199333, Lot Number I	8	2015-10-27

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.