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

Vanguard® Knee System

579 catalogue numbers from 189026, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.

Registry build 21.09.26
21manufacturers in China registered for this device type
579catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JWH
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
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
Changzhou Wastonortho Medical Appliance Co., Ltd. Changzhou Jiangsu Contract manufacturer 5

Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Record

Regulatory record for Vanguard® Knee System
Listed by Biomet Orthopedics, United States
FDA product code JWH
Device type Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class Class 2
Regulation 21 CFR 888.3560
510(k) K050222
Record published 2015-10-24
Record revised 2025-05-30 (version 11)

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Vanguard® Knee System
Catalogue number Size Per pack Status
189026 16 MM 63 MM In distribution
183548 18 MM 71/75 MM In distribution
CP103410 13 MM 71/75 MM In distribution
183504 14 MM 59 MM In distribution
184143 5 MM 62.5 MM In distribution
183643 13 MM 71/75 MM In distribution
183500 10 MM 59 MM In distribution
184786 34 MM 7.8 MM In distribution
183033 72.5 mm Left In distribution
183910 20 mm 79/83 mm In distribution
183890 20 mm 71/75 mm In distribution
183626 16 MM 63/67 MM In distribution
EP-183760 10 MM 79/83 MM In distribution
183100 55 mm Right In distribution
183652 22 MM 71/75 MM In distribution
184226 10 MM 70 MM In distribution
EP-189000 10 MM 59 MM In distribution
183592 22 MM 87/91 MM In distribution
183508 18 MM 59 MM In distribution
189444 14 MM 67 MM In distribution
189426 16 MM 63 MM In distribution
183924 14 mm 87/91 mm In distribution
CP113627 75 MM In distribution
183066 62.5 mm Left In distribution
189063 13 MM 71 MM In distribution
183212 70 mm Right In distribution
184204 10 MM 65 MM In distribution
184296 5 MM In distribution
184520 55 mm Left In distribution
183674 24 MM 79/83 MM In distribution
184768 37 mm 10 mm In distribution
183690 20 MM 87/91 MM In distribution
184788 37 MM 8.6 MM In distribution
184764 31 MM 8 MM In distribution
183544 14 MM 71/75 MM In distribution
183788 18 MM 87/91 MM In distribution
183514 24 MM 59 MM In distribution
183110 67.5 mm Right In distribution
CP103452 11 MM 79/83 MM In distribution
183130 67.5 mm Left In distribution
EP-189123 13 MM 83 MM In distribution
184242 10 MM 60 MM In distribution
183126 62.5 mm Left In distribution
189646 16 MM 67 MM In distribution
183428 18 MM 63/67 MM In distribution
189668 18 MM 71 MM In distribution
184102 5 MM 60 MM In distribution
CP113645 72.5 MM In distribution
189052 22 MM 67 MM In distribution
183632 22 MM 63/67 MM In distribution
184514 75 mm Right In distribution
189060 10 MM 71 MM In distribution
183213 72.5 mm Right In distribution
185064 14 mm 63/67 mm In distribution
CP103424 11 MM 63/67 MM In distribution
185112 22 mm 79/83 mm In distribution
189322 12 MM 83 MM In distribution
183768 18 MM 79/83 MM In distribution
184708 37 mm 10 mm In distribution
183040 55 mm Right In distribution
183412 22 MM 59 MM In distribution
EP-183582 12 MM 87/91 MM In distribution
189121 11 MM 83 MM In distribution
189220 10 MM 63 MM In distribution
183408 18 MM 59 MM In distribution
183480 10 MM 87/91 MM In distribution
184766 34 MM 8.5 MM In distribution
CP113584 18 MM 87 MM In distribution
185120 10 mm 87/91 mm In distribution
189086 16 MM 75 MM In distribution
CP113611 55 MM In distribution
184190 10 MM 80 MM In distribution
CP103408 11 MM 71/75 MM In distribution
184223 10 MM 62.5 MM In distribution
183730 20 MM 63/67 MM In distribution
183030 67.5 mm Left In distribution
185114 24 mm 79/83 mm In distribution
CP103418 13 MM 87/91 MM In distribution
183466 16 MM 79/83 MM In distribution
183400 10 MM 59 MM In distribution
189226 16 MM 63 MM In distribution
183226 62.5 mm Left In distribution
CP113585 20 MM 87 MM In distribution
184145 5 MM 67.5 MM In distribution
183200 55 mm Right In distribution
189482 12 MM 75 MM In distribution
183884 14 mm 71/75 mm In distribution
183634 24 MM 63/67 MM In distribution
183602 12 MM 59 MM In distribution
184241 10 MM 57.5 MM In distribution
184726 34 MM 7.8 MM In distribution
185106 16 mm 79/83 mm In distribution
185086 16 mm 71/75 mm In distribution
184246 10 MM 70 MM In distribution
183530 20 MM 63/67 MM In distribution
184299 In distribution
183780 10 MM 87/91 MM In distribution
184513 72.5 mm Right In distribution
189262 12 MM 71 MM In distribution
183630 20 MM 63/67 MM In distribution
183528 18 MM 63/67 MM In distribution
CP103448 11 MM 71/75 MM In distribution
189140 10 MM 87 MM In distribution
183640 10 MM 71/75 MM In distribution
184186 10 MM 70 MM In distribution
183206 62.5 mm Right In distribution
184530 67.5 mm Left In distribution
185084 14 mm 71/75 mm In distribution
183786 16 MM 87/91 MM In distribution
183560 10 MM 79/83 MM In distribution
CP113634 60 MM In distribution
184140 5 MM 55 MM In distribution
189110 20 MM 79 MM In distribution
189664 14 MM 71 MM In distribution
183782 12 MM 87/91 MM In distribution
183922 12 mm 87/91 mm In distribution
184760 25 MM 8 MM In distribution
183420 10 MM 63/67 MM In distribution
189248 18 MM 67 MM In distribution
189520 10 MM 83 MM In distribution
184720 25 MM 6.2 MM In distribution
183099 2 In distribution
CP103428 11 MM 71/75 MM In distribution
183880 10 mm 71/75 mm In distribution
183794 24 MM 87/91 MM In distribution
183210 67.5 mm Right In distribution
183026 62.5 mm Left In distribution
CP103426 13 MM 63/67 MM In distribution
184270 15 MM 80 MM In distribution
183116 80 mm Right In distribution
184148 5 MM 75 MM In distribution
184224 10 MM 65 MM In distribution
185102 12 mm 79/83 mm In distribution
183234 75 mm Left In distribution
184286 15 MM 70 MM In distribution
189500 10 MM 79 MM In distribution
189242 12 MM 67 MM In distribution
189081 11 MM 75 MM In distribution
183220 55 mm Left In distribution
184122 5 MM 60 MM In distribution
CP113615 60 MM In distribution
183016 80 mm Right In distribution
183534 24 MM 63/67 MM In distribution
184208 10 MM 75 MM In distribution
185100 10 mm 79/83 mm In distribution
CP113613 57.5 MM In distribution
189708 18 MM 79 MM In distribution
183702 12 MM 59 MM In distribution
184263 15 MM 62.5 MM In distribution
183048 65 mm Right In distribution
CP103436 11 MM 87/91 MM In distribution
183053 72.5 mm Right In distribution
184504 60 mm Right In distribution
183926 16 mm 87/91 mm In distribution
183686 16 MM 87/91 MM In distribution
CP113621 67.5 MM In distribution
189506 16 MM 79 MM In distribution
183606 16 MM 59 MM In distribution
183792 22 MM 87/91 MM In distribution
183600 10 MM 59 MM In distribution
CP103444 11 MM 63/67 MM In distribution
183900 10 mm 79/83 mm In distribution
189428 18 MM 63 MM In distribution
EP-189082 12 MM 75 MM In distribution
183624 14 MM 63/67 MM In distribution
183570 20 MM 79/83 MM In distribution
CP113631 55 MM In distribution
183106 62.5 mm Right In distribution
189328 18 MM 83 MM In distribution
183074 75 mm Left In distribution
CP103434 13 MM 79/83 MM In distribution
185130 20 mm 87/91 mm In distribution
CP103456 11 MM 87/91 MM In distribution
183574 24 MM 79/83 MM In distribution
189662 12 MM 71 MM In distribution
183908 18 mm 79/83 mm In distribution
184288 15 MM 75 MM In distribution
183010 67.5 mm Right In distribution
184168 5 MM 75 MM In distribution
183006 62.5 mm Right In distribution
189123 13 MM 83 MM In distribution
184202 10 MM 60 MM In distribution
183013 72.5 mm Right In distribution
183582 12 MM 87/91 MM In distribution
184141 5 MM 57.5 MM In distribution
189666 16 MM 71 MM In distribution
184221 10 MM 57.5 MM In distribution
183204 60 mm Right In distribution
183566 16 MM 79/83 MM In distribution
184782 28 MM 6.2 MM In distribution
EP-184786 34 MM 7.8 MM In distribution
183622 12 MM 63/67 MM In distribution
184790 25 MM 8 MM In distribution
185072 22 mm 63/67 mm In distribution
183752 22 MM 71/75 MM In distribution
CP103442 13 MM 59 MM In distribution
189524 14 MM 83 MM In distribution
CP113643 70 MM In distribution
184262 15 MM 60 MM In distribution
184794 37 MM 10 MM In distribution
183664 14 MM 79/83 MM In distribution
183668 18 MM 79/83 MM In distribution
183720 10 MM 63/67 MM In distribution
184240 10 MM 55 MM In distribution
183222 57.5 mm Left In distribution
CP113646 75 MM In distribution
183102 57.5 mm Right In distribution
183423 13 MM 63/67 MM In distribution
184110 5 MM 80 MM In distribution
183228 65 mm Left In distribution
183532 22 MM 63/67 MM In distribution
183692 22 MM 87/91 MM In distribution
183726 16 MM 63/67 MM In distribution
183460 10 MM 79/83 MM In distribution
184724 31 MM 6.2 MM In distribution
183754 24 MM 71/75 MM In distribution
EP-184768 37 MM 10 MM In distribution
183543 13 MM 71/75 MM In distribution
184163 5 MM 62.5 MM In distribution
183028 65 mm Left In distribution
185060 10 mm 63/67 mm In distribution
183446 16 MM 71/75 MM In distribution
CP103402 13 MM 59 MM In distribution
183886 16 mm 71/75 mm In distribution
189282 12 MM 75 MM In distribution
CP113629 80 MM In distribution
183414 24 MM 59 MM In distribution
185092 22 mm 71/75 mm In distribution
185104 14 mm 79/83 mm In distribution
189300 10 MM 79 MM In distribution
183404 14 MM 59 MM In distribution
185094 24 mm 71/75 mm In distribution
EP-183683 13 MM 87/91 MM In distribution
183586 16 MM 87/91 MM In distribution
183864 14 mm 63/67 mm In distribution
189480 10 MM 75 MM In distribution
189050 20 MM 67 MM In distribution
184225 10 MM 67.5 MM In distribution
183510 20 MM 59 MM In distribution
184205 10 MM 67.5 MM In distribution
CP103416 11 MM 87/91 MM In distribution
183614 24 MM 59 MM In distribution
183712 22 MM 59 MM In distribution
183930 20 mm 87/91 mm In distribution
184184 10 MM 65 MM In distribution
184181 10 MM 57.5 MM In distribution
183036 80 mm Left In distribution
183520 10 MM 63/67 MM In distribution
184290 15 MM 80 MM In distribution
189088 18 MM 75 MM In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Prophecy® Microport Orthopedics Inc. 4,423
Exult Knee Replacement System Corentec Co., Ltd. 1,770
Freedom Maxx Orthopedics Inc. 1,693
Legion Smith & Nephew, Inc. 1,534
MyKnee Medacta International SA 1,466
Journey Smith & Nephew, Inc. 1,339
Persona® Zimmer, Inc. 1,254
DJO Surgical Encore Medical, L.P. 1,131
U2 Total Knee System United Orthopedic Corp. 1,078
CKS Plus Shalby Advanced Technologies, Inc. 1,024
Lospa Modular Knee System Corentec Co., Ltd. 1,020
Natural-Knee® Zimmer, Inc. 980

Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K080528 2008-06-17
K022586 2002-08-15

Recalls Naming This Product

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

Recalls naming the identifiers of Vanguard® Knee System
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Biomet, Inc. 510(k) number 2024-03-13 Class II Process change control Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. 19 units (1 US, 18 OUS)
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 2020-04-17 Class II Process control Potential presence of elevated endotoxin levels that exceed the specification limit 46 units 2021-06-25
Biomet, Inc. 510(k) number 2020-04-17 Class II Process control Potential presence of elevated endotoxin levels that exceed the specification limit 11 units 2021-06-25
Biomet, Inc. 510(k) number 2020-04-17 Class II Process control Potential presence of elevated endotoxin levels that exceed the specification limit 107 units 2021-06-25
Biomet, Inc. 510(k) number 2020-04-17 Class II Process control Potential presence of elevated endotoxin levels that exceed the specification limit 93 units 2021-06-25
Biomet, Inc. 510(k) number 2020-04-17 Class II Process control Potential presence of elevated endotoxin levels that exceed the specification limit 91 units 2021-06-25
Biomet, Inc. 510(k) number 2018-12-21 Class II Under Investigation by firm Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. 45 units 2020-05-13
Biomet, Inc. 510(k) number 2018-12-21 Class II Under Investigation by firm Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. 90 units 2020-05-13
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 2018-05-18 Class II Under Investigation by firm One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented. 16 2020-03-31
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
Biomet, Inc. 510(k) number 2017-09-29 Class II Labeling mix-ups Knee implant components (tibial bearings) are labeled with the incorrect size. 24 2019-04-17
Biomet, Inc. 510(k) number 2017-09-29 Class II Labeling mix-ups Knee implant components (tibial bearings) are labeled with the incorrect size. 24 2019-04-17
Biomet, Inc. 510(k) number 2017-02-17 Class II Process design Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. 28,253 in total 2018-01-29
Biomet, Inc. 510(k) number 2017-01-04 Class II Process change control packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery. 15,000 2018-06-11
Biomet, Inc. 510(k) number 2016-08-09 Class II Labeling mix-ups Contents of the package do not match the product labeling.
Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM
Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM
Risks:
Adverse health outcomes that could occur as a r		 5 2017-05-17
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 149 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-10-04 Not classified Error in labeling Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. 2013-04-08
Biomet, Inc. 510(k) number 2011-07-06 Not classified Employee error The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless. 8 2012-09-26
Biomet, Inc. 510(k) number 2010-04-20 Not classified Process control A knee implant labeled as left was opened and the package actually contained a right knee implant. 5 2011-01-19
Biomet, Inc. 510(k) number 2008-09-22 Not classified Process control The package is properly labeled, but the laser etch for size incorrectly reads “16 X 63/63” instead of the correct size, “16 X 63/67”. 11 2009-09-22
Biomet, Inc. 510(k) number 2008-02-12 Not classified Packaging process control Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result i 4 2009-12-22
Biomet, Inc. 510(k) number 2008-02-12 Not classified Packaging process control Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result i 8 2009-12-22
Biomet, Inc. 510(k) number 2007-08-31 Not classified Packaging process control Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component. 16 2008-06-04

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