What is FDA product code OIY?

Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.

Orthopedic › ProstheticProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Klassic Tibial Insert, PS-Post, Std Poly

Name: Klassic Tibial Insert, PS-Post, Std Poly
Brand: Klassic Tibial Insert, PS-Post, Std Poly

Tibial Insert, PS-Post, Std Poly, Size 3, 24mm

Registry build 21.09.26

8manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OIY
Manufacturer	City	Province	Registered as	Device types
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
b-ONE Medical (Beijing) Co., Ltd.	Beijing	Beijing	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
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for Klassic Tibial Insert, PS-Post, Std Poly
Listed by	Total Joint Orthopedics, Inc., United States
FDA product code	OIY
Device type	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device class	Class 2
Regulation	21 CFR 888.3560
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K232414
Record published	2023-09-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: The Klassic Knee System should be stored in a clean, dry location at room temperature

Catalogue Numbers

Catalogue numbers for Klassic Tibial Insert, PS-Post, Std Poly
Catalogue number	Size	Status
5304.03.024	Size 3, 24mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Persona®	Zimmer, Inc.	552
DJO Surgical	Encore Medical, L.P.	415
Genflex2 Total Knee System	Globus Medical, Inc.	389
Persona® Vivacit-E®	Zimmer, Inc.	332
Truliant, Activit-E	Exactech, Inc.	272
TriVerse Meniscal Insert PS	Signature Orthopaedics PTY Limited	220
U2™ Knee	United Orthopedic Corp.	195
BKS E-Vitalize	Ortho Development Corp.	193
Vanguard XP Instrumentation	Biomet Orthopedics	169
Attune	Depuy (Ireland)	161
Vanguard Complete Knee System	Biomet Orthopedics	153
EXp Tibial Inserts and Patellar Components	Globus Medical, Inc.	144

Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

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.