Who else makes this device?

Name: Vanguard®
Brand: Vanguard®

Orthopedic › ProstheticProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Vanguard®

74 catalogue numbers from 599304, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. 12 manufacturers in China are registered for this product code.

Registry build 21.09.26

12manufacturers in China registered for this device type

74catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MBH
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Guangzhou Aquila Precise Tools Limited	Guangzhou	Guangdong	Contract manufacturer	28
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	10
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
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for Vanguard®
Listed by	Biomet Orthopedics, United States
FDA product code	MBH
Device type	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3565
510(k)	K113550
Record published	2023-06-13
Record revised	2025-05-30 (version 13)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for Vanguard®
Catalogue number	Size	Status
599304		In distribution
32-483890	20MM X 87/91MM	In distribution
SSI002100	63/67 mm Width x 10 mm Height	In distribution
32-483728	18 mm X 63/67 mm	In distribution
599301		In distribution
32-489026	16 mm X 63 mm	In distribution
32-489092	22 mm X 75 mm	In distribution
32-489120	10 mm X 83 mm	In distribution
32-489022	12 mm X 63 mm	In distribution
32-489068	18 mm X 71 mm	In distribution
32-489148	18MM X 87MM	In distribution
SSI004863	12×87/91 mm	In distribution
32-489000	10 mm X 59 mm	In distribution
32-483868	18MM X 79/83MM	In distribution
32-483106	62.5 mm	In distribution
32-483130	67.5 mm	In distribution
32-483124	60 mm	In distribution
32-483884	14MM X 87/91MM	In distribution
32-483720	10 mm X 63/67 mm	In distribution
32-483822	12 mm X 63/67 mm	In distribution
32-483810	20 mm X 59 mm	In distribution
32-483880	10 mm X 87/91 mm	In distribution
SSI002104	71/75 mm Width x 12 mm Height	In distribution
32-489046	16 mm X 67 mm	In distribution
SSI002106	79/83 mm Width x 10 mm Height	In distribution
32-483746	16 mm X 71/75 mm	In distribution
32-483780	10 mm X 87/91 mm	In distribution
32-489101	11 mm X 79 mm	In distribution
32-483824	14 mm X 63/67 mm	In distribution
32-483134	75 mm	In distribution
SSI002102	63/67 mm Width x 14 mm Height	In distribution
32-483870	20 mm X 79/83 mm	In distribution
32-489088	18 mm X 75 mm	In distribution
32-489048	18 mm X 67 mm	In distribution
32-483764	14 mm X 79/83 mm	In distribution
32-489140	10MM X 87MM	In distribution
32-489070	20 mm X 71 mm	In distribution
32-483110	67.5 mm	In distribution
32-483802	12 mm X 59 mm	In distribution
SSI004861	14×59 mm	In distribution
32-483026	62.5 mm	In distribution
32-489140	10 mm X 87 mm	In distribution
32-483724	14 mm X 63/67 mm	In distribution
32-483708	18 mm X 59 mm	In distribution
SSI004859	10×59 mm	In distribution
32-489063	13 mm X 71 mm	In distribution
32-489010	20 mm X 59 mm	In distribution
32-483788	18 mm X 87/91 mm	In distribution
32-483100	55 mm	In distribution
32-483884	14 mm X 87/91 mm	In distribution
32-483726	16 mm X 63/67 mm	In distribution
32-489112	22 mm X 79 mm	In distribution
32-483000	55 mm	In distribution
599304		In distribution
32-489110	20 mm X 79 mm	In distribution
32-483842	12 mm X 71/75 mm	In distribution
32-483766	16 mm X 79/83 mm	In distribution
32-483868	18 mm X 79/83 mm	In distribution
32-489080	10 mm X 75 mm	In distribution
32-489082	12 mm X 75 mm	In distribution
32-489134	24 mm X 83 mm	In distribution
32-483892	22 mm X 87/91 mm	In distribution
32-489041	11 mm X 67 mm	In distribution
32-483872	22 mm X 79/83 mm	In distribution
32-483880	10MM X 87/91MM	In distribution
32-483870	20MM X 79/83MM	In distribution
32-489004	14 mm X 59 mm	In distribution
32-483700	10 mm X 59 mm	In distribution
32-489124	14 mm X 83 mm	In distribution
32-483113	72.5 mm	In distribution
32-489006	16 mm X 59 mm	In distribution
32-483120	55 mm	In distribution
32-483760	10 mm X 79/83 mm	In distribution
SSI002108	79/83 mm Width x 14 mm Height	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prophecy	Microport Orthopedics Inc.	4,272
Triathlon	Howmedica Osteonics Corp	712
Instrument	Howmedica Osteonics Corp	709
Persona® Vivacit-E®	Zimmer, Inc.	499
Arthrex®	Arthrex, Inc.	494
Persona®	Zimmer, Inc.	441
Legion	Smith & Nephew, Inc.	397
U2 Total Knee System	United Orthopedic Corp.	286
Attune	Depuy (Ireland)	234
DJO Surgical	Encore Medical, L.P.	191
Vanguard XP Instrumentation	Biomet Orthopedics	150
Truliant®	Exactech, Inc.	142

Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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.