Orthopedic › ProstheticProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Vanguard® 360 Instrument

Reamer 10MM

Registry build 21.09.26
5manufacturers in China registered for this device type
98catalogue 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 MBV
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
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 Vanguard® 360 Instrument
Listed by Biomet Orthopedics, United States
FDA product code MBV
Device type Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Device class Class 2
Regulation 21 CFR 888.3560
510(k) K093293
Record published 2023-06-13
Record revised 2025-05-30 (version 8)

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® 360 Instrument
Catalogue number Size Status
32-360666 18 mm X 160 mm In distribution
32-360261 57.5 mm In distribution
32-360340 55/57.5 mm X 5 mm In distribution
32-360390 80 X 10MM RL/LM In distribution
32-360096 83 mm In distribution
32-488474 In distribution
32-360893 23 mm In distribution
32-360623 23MM In distribution
32-360654 14 mm X 160 mm In distribution
32-360891 REAMER 21MM In distribution
32-360881 REAMER 11MM In distribution
32-360894 24 mm In distribution
32-360613 13 mm In distribution
32-360648 16MM X 120MM In distribution
32-360288 75 mm In distribution
32-360090 59 mm In distribution
32-360672 16MM X 200MM In distribution
32-360285 67.5 mm In distribution
32-360097 87 mm In distribution
32-360088 7.5 mm In distribution
32-360621 21 mm In distribution
32-360614 14MM In distribution
32-360644 12MM X 120MM In distribution
32-360882 REAMER 12MM In distribution
32-360667 19MM X 160MM In distribution
32-360632 16MM X 40MM In distribution
32-360892 22 mm In distribution
32-360685 21 mm X 200 mm In distribution
32-360636 12MM X 80MM In distribution
32-360886 16 mm In distribution
32-360665 17 mm X 160 mm In distribution
32-360683 19MM X 200MM In distribution
32-360085 0 mm In distribution
32-360290 80 mm In distribution
32-360112 In distribution
32-360663 15 mm X 160 mm In distribution
32-360426 70/72.5 mm X 10 mm In distribution
32-360634 10MM X 80MM In distribution
32-360676 12 mm X 200 mm In distribution
32-360284 65 mm In distribution
32-360624 24MM In distribution
32-360681 17MM X 200MM In distribution
32-360887 REAMER 17MM In distribution
32-488471 2.5 mm In distribution
32-360621 21MM In distribution
32-360636 12 mm X 80 mm In distribution
32-360665 17MM X 160MM In distribution
32-360111 In distribution
32-360091 63 mm In distribution
32-360598 In distribution
32-360092 67 mm In distribution
32-360668 12MM X 200MM In distribution
32-360616 16MM In distribution
32-360644 12 mm X 120 mm In distribution
32-360676 12MM X 200MM In distribution
32-360884 REAMER 14MM In distribution
32-360640 16MM X 80MM In distribution
32-360428 75 mm X 10 mm In distribution
32-488470 0 mm In distribution
32-360893 REAMER 23MM In distribution
32-360667 19 mm X 160 mm In distribution
32-360281 57.5 mm In distribution
32-360684 20MM X 200MM In distribution
32-360634 10 mm X 80 mm In distribution
32-360264 65 mm In distribution
32-360611 11MM In distribution
32-360664 16MM X 160MM In distribution
32-360610 10MM In distribution
32-360638 14MM X 80MM In distribution
32-360660 12 mm X 160 mm In distribution
32-360623 23 mm In distribution
32-360350 80 mm X 5 mm In distribution
32-360348 75 mm X 5 mm In distribution
32-360670 14 mm X 200 mm In distribution
32-360424 65/67.5 mm X 10 mm In distribution
32-360660 12MM X 160MM In distribution
32-360686 22 mm X 200 mm In distribution
32-360654 14MM X 160MM In distribution
32-360622 22 mm In distribution
32-360679 15 mm X 200 mm In distribution
32-360282 60 mm In distribution
32-360615 15MM In distribution
32-360298 In distribution
32-360880 10MM In distribution
32-360889 REAMER 19MM In distribution
32-360691 21MM X 160MM In distribution
32-360678 14MM X 200MM In distribution
32-360662 14MM X 160MM In distribution
32-360630 14MM X 40MM In distribution
32-360626 10 mm X 40 mm In distribution
32-360262 60 mm In distribution
32-360670 14MM X 200MM In distribution
32-488472 5 mm In distribution
32-360260 55 mm In distribution
32-360648 16 mm X 120 mm In distribution
32-360599 In distribution
32-360620 20MM In distribution
32-360888 18 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vanguard XP® Instrumentation Biomet Orthopedics 130
Vanguard Complete Knee System Biomet Orthopedics 106
Biomet® Knee System Biomet Orthopedics 94
Maxim Knee System Biomet Orthopedics 73
Vanguard Knee System Biomet Orthopedics 49
Vanguard Instrument Biomet Orthopedics 44
Vanguard 360 Revision System Biomet Orthopedics 43
Biomet® 360 Biomet Orthopedics 39
Biomet® 360 Instrument Biomet Orthopedics 36
Vanguard 360 Biomet Orthopedics 30
Biomet 360 Knee System Biomet Orthopedics 27
Vanguard® SSK 360 Knee System Biomet Orthopedics 19

Showing 12 of 41. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Recalls Naming This Product

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

Recalls naming the identifiers of Vanguard® 360 Instrument
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Biomet, Inc. 510(k) number 2020-12-01 Class II Process control Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure 21 units 2022-07-08
Biomet, Inc. 510(k) number 2018-08-02 Class II Under Investigation by firm The implant only has one bolt in the sterile package but it should have had two. 16 2019-04-25
Biomet, Inc. 510(k) number 2018-08-02 Class II Under Investigation by firm The implant only has one bolt in the sterile package but it should have had two. 16 2019-04-25
Biomet, Inc. 510(k) number 2016-08-08 Class II Process control The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can 454 2017-06-05
Biomet, Inc. 510(k) number 2014-07-01 Class II Process change control The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component. 461 2015-10-30

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer