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

Vanguard

Name: Vanguard
Brand: Vanguard

85 catalogue numbers from 32-483892, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26

8manufacturers in China registered for this device type

85catalogue numbers in this listing

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 Vanguard
Listed by	Biomet Orthopedics, 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
510(k)	K113550
Record published	2016-09-22
Record revised	2025-05-30 (version 9)

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
Sizes	Width 71 to 79 mm

Catalogue Numbers

Catalogue numbers for Vanguard
Catalogue number	Size	Status
32-483892	22MM X 87/91MM	In distribution
32-483890	20 mm X 87/91 mm	In distribution
32-483024	60 mm	In distribution
32-483016	80 mm	In distribution
32-483013	72.5 mm	In distribution
32-489074	24 mm X 71 mm	In distribution
SSI001054	70 L	In distribution
32-489043	13 mm X 67 mm	In distribution
32-489030	20 mm X 63 mm	In distribution
32-483014	75 mm	In distribution
32-483830	20 mm X 63/67 mm	In distribution
32-483032	70 mm	In distribution
32-483840	10 mm X 71/75 mm	In distribution
32-483882	12MM X 87/91MM	In distribution
32-483762	12 mm X 79/83 mm	In distribution
32-483806	16 mm X 59 mm	In distribution
32-489028	18 mm X 63 mm	In distribution
32-483126	62.5 mm	In distribution
32-483860	10 mm X 79/83 mm	In distribution
32-483116	80 mm	In distribution
32-483744	14 mm X 71/75 mm	In distribution
32-483784	14 mm X 87/91 mm	In distribution
32-489094	24 mm X 75 mm	In distribution
32-483852	22 mm X 71/75 mm	In distribution
32-483826	16 mm X 63/67 mm	In distribution
32-489123	13 mm X 83 mm	In distribution
32-483844	14 mm X 71/75 mm	In distribution
SSI001048	62.5 L	In distribution
32-483740	10 mm X 71/75 mm	In distribution
32-489126	16 mm X 83 mm	In distribution
32-483886	16 mm X 87/91 mm	In distribution
32-489060	10 mm X 71 mm	In distribution
32-483814	24 mm X 59 mm	In distribution
32-489103	13 mm X 79 mm	In distribution
32-483706	16 mm X 59 mm	In distribution
32-489104	14 mm X 79 mm	In distribution
32-489044	14 mm X 67 mm	In distribution
32-489144	14MM X 87MM	In distribution
32-489132	22 mm X 83 mm	In distribution
32-483882	12 mm X 87/91 mm	In distribution
32-483828	18 mm X 63/67 mm	In distribution
32-489148	18 mm X 87 mm	In distribution
32-483722	12 mm X 63/67 mm	In distribution
599308		In distribution
32-483022	57.5 mm	In distribution
32-483104	60 mm	In distribution
SSI001050	65 L	In distribution
32-489150	20 mm X 87 mm	In distribution
32-489002	12 mm X 59 mm	In distribution
SSI002132	10 x 79	In distribution
32-483748	18 mm X 71/75 mm	In distribution
32-483874	24MM X 79/83MM	In distribution
32-483122	57.5 mm	In distribution
32-483832	22 mm X 63/67 mm	In distribution
32-489122	12 mm X 83 mm	In distribution
32-483020	55 mm	In distribution
32-489130	20 mm X 83 mm	In distribution
32-483030	67.5 mm	In distribution
32-483133	72.5 mm	In distribution
32-489042	12 mm X 67 mm	In distribution
32-489081	11 mm X 75 mm	In distribution
32-483888	18 mm X 87/91 mm	In distribution
32-483846	16 mm X 71/75 mm	In distribution
32-489050	20 mm X 67 mm	In distribution
32-489072	22 mm X 71 mm	In distribution
32-483136	80 mm	In distribution
32-483808	18 mm X 59 mm	In distribution
SSI001052	67.5 L	In distribution
32-483820	10 mm X 63/67 mm	In distribution
32-483786	16 mm X 87/91 mm	In distribution
32-483112	70 mm	In distribution
32-483812	22 mm X 59 mm	In distribution
32-483800	10 mm X 59 mm	In distribution
32-483901		In distribution
SSI001046	60 L	In distribution
32-483872	22MM X 79/83MM	In distribution
SSI001059	75 L	In distribution
32-489142	12 mm X 87 mm	In distribution
SSI002128	10 x 71	In distribution
32-483768	18 mm X 79/83 mm	In distribution
32-483002	57.5 mm	In distribution
32-483834	24 mm X 63/67 mm	In distribution
32-489108	18 mm X 79 mm	In distribution
32-483114	75 mm	In distribution
32-483742	12 mm X 71/75 mm	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

Recalls Naming This Product

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

Recalls naming the identifiers of Vanguard
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2022-12-29	Class II	Labeling Change Control	Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).	157 units
Biomet, Inc.	510(k) number	2022-12-29	Class II	Labeling Change Control	Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).	91 units
Biomet, Inc.	510(k) number	2018-10-22	Class II	Labeling mix-ups	Label on the outer carton or the patient labels does not match label on the inner sterile packaging	8 units	2019-12-11
Biomet, Inc.	510(k) number	2018-10-22	Class II	Labeling mix-ups	Label on the outer carton or the patient labels does not match label on the inner sterile packaging	8 units	2019-12-11
Biomet, Inc.	510(k) number	2018-05-24	Class II	Under Investigation by firm	Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.	48	2020-04-07
Biomet, Inc.	510(k) number	2018-05-11	Class II	Under Investigation by firm	The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.	169	2019-11-21
Biomet, Inc.	510(k) number	2017-10-03	Class II	Error in labeling	The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.	8	2018-08-23

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.