Vanguard(TM)
11 catalogue numbers from 32-483000, 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.
21manufacturers in China registered for this device type
11catalogue 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.
| 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
| 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) | K113550 |
| Record published | 2016-09-21 |
| Record revised | 2025-05-30 (version 9) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-483000 | 55 MM | In distribution |
| 32-488261 | SIZE 63 | In distribution |
| 32-489022 | 12MM X 63MM | In distribution |
| 32-488260 | SIZE 59 | In distribution |
| 32-489048 | 18MM X 67MM | In distribution |
| 32-488262 | SIZE 67 | In distribution |
| 32-488266 | SIZE 83 | In distribution |
| 32-486530 | 25MM, 3-PEG | In distribution |
| 32-488263 | SIZE 71 | In distribution |
| 32-489128 | 18MM X 83MM | In distribution |
| 32-486534 | 37MM, 3-PEG | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K080528 | 2008-06-17 |
| K022586 | 2002-08-15 |
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| 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 | 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 | 2018-10-22 | 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 | 2018-08-02 | 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 | 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 | 2016-12-15 | Class II | Material/Component Contamination | Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product c | 26 | 2018-06-29 |
| 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 | 2015-04-16 | Class III | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 1315 | 2016-05-16 |
| 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.