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.

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

Ic-Head Biolox®delta Taper 12/14

Name: ic-head Biolox®delta taper 12/14
Brand: ic-head Biolox®delta taper 12/14

8 catalogue numbers from 25863200, listed by implantcast GmbH, Germany, under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

8catalogue 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 ic-head Biolox®delta taper 12/14
Listed by	implantcast GmbH, Germany
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	Complaint-file establishment, Manufacturer, Exporter
Record published	2018-08-31
Record revised	2020-09-09 (version 2)

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 ic-head Biolox®delta taper 12/14
Catalogue number	Size	Status
25863200	Size 32mm S	In distribution
25863215	Size 32mm XL	In distribution
25863210	Size 32mm L	In distribution
25863605	Size 36mm M	In distribution
25863600	Size 36mm S	In distribution
25863610	Size 36mm L	In distribution
25863205	Size 32mm M	In distribution
25863615	Size 36mm XL	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
K252451	2026-04-24

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.