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.

TheRay Collared and Collarless Femoral Stem · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented → Orthopedic

Name: TheRay Collared and Collarless Femoral Stem
Brand: TheRay Collared and Collarless Femoral Stem

5manufacturers in China registered for this device type

2catalogue 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 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 TheRay Collared and Collarless Femoral Stem
Listed by	Nextstep Arthropedix, United States
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
510(k)	K241875
Record published	2024-12-04

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

Catalogue Numbers

Catalogue numbers for TheRay Collared and Collarless Femoral Stem
Catalogue number	Size	Status
12-81-0005		In distribution
12-81-0007		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

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 TheRay Collared and Collarless Femoral Stem
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Theken Companies, LLC	510(k) number	2025-09-11	Class II	Package design/selection	Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.	409

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.

TheRay Collared and Collarless Femoral Stem