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.

InSitu Hip System · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented → Orthopedic

Name: InSitu Hip System
Brand: InSitu Hip System

5manufacturers in China registered for this device type

50catalogue 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 InSitu Hip System
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)	K161184
Record published	2018-02-15
Record revised	2020-04-06 (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, manufacturing date
Sizes	Outer diameter 28 to 68 mm; length 112 to 142 mm

Catalogue Numbers

Catalogue numbers for InSitu Hip System
Catalogue number	Size	Status
10-20-3200	Outer Diameter 32 mm	In distribution
10-10-0010	Length 134 mm	In distribution
10-32-0058	Outer Diameter 58 mm	In distribution
10-20-4004	Outer Diameter 40 mm	In distribution
10-20-4002	Outer Diameter 40 mm	In distribution
10-40-3650	Outer Diameter 50 mm	In distribution
10-10-0008	Length 129 mm	In distribution
10-33-0052	Outer Diameter 52 mm	In distribution
10-10-0006	Length 125 mm	In distribution
10-21-2802	Outer Diameter 28 mm	In distribution
10-11-0011	Length 136 mm	In distribution
10-21-2800	Outer Diameter 28 mm	In distribution
10-21-4001	Outer Diameter 40 mm	In distribution
10-11-0003	Length 119 mm	In distribution
10-20-3601	Outer Diameter 36 mm	In distribution
10-33-0068	Outer Diameter 68 mm	In distribution
10-20-2800	Outer Diameter 28 mm	In distribution
10-20-4000	Outer Diameter 40 mm	In distribution
10-21-3201	Outer Diameter 32 mm	In distribution
10-10-0012	Length 138 mm	In distribution
10-11-0001	Length 115 mm	In distribution
10-10-0014	Length 142 mm	In distribution
10-33-0048	Outer Diameter 48 mm	In distribution
10-10-0004	Length 121 mm	In distribution
10-11-0009	Length 132 mm	In distribution
10-33-0064	Outer Diameter 64 mm	In distribution
10-32-0054	Outer Diameter 54 mm	In distribution
10-32-0046	Outer Diameter 46 mm	In distribution
10-10-0000	Length 112 mm	In distribution
10-11-0013	Length 140 mm	In distribution
10-21-3603	Outer Diameter 36 mm	In distribution
10-32-0050	Outer Diameter 50 mm	In distribution
10-11-0005	Length 123 mm	In distribution
10-40-3246	Outer Diameter 46 mm	In distribution
10-20-3603	Outer Diameter 36 mm	In distribution
10-10-0002	Length 117 mm	In distribution
10-20-3202	Outer Diameter 32 mm	In distribution
10-33-0056	Outer Diameter 56 mm	In distribution
10-21-3601	Outer Diameter 36 mm	In distribution
10-33-0060	Outer Diameter 60 mm	In distribution
10-20-3204	Outer Diameter 32 mm	In distribution
10-11-0007	Length 127 mm	In distribution
10-40-3654	Outer Diameter 54 mm	In distribution
10-32-0068	Outer Diameter 68 mm	In distribution
10-32-0062	Outer Diameter 62 mm	In distribution
10-21-3203	Outer Diameter 32 mm	In distribution
10-33-0044	Outer Diameter 44 mm	In distribution
10-32-0066	Outer Diameter 66 mm	In distribution
10-20-2802	Outer Diameter 28 mm	In distribution
10-21-4003	Outer Diameter 40 mm	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
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
Continuum® Trilogy® Allofit® Vivacit-E®	Zimmer, Inc.	22

Showing 12 of 164. All products under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

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.

InSitu Hip System

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies