Maxim Knee System
73 catalogue numbers from 11-146744, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
73catalogue 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.
| 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
| 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) | K142933 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-146744 | 24MM 63/67MM | In distribution |
| 11-146542 | 22MM 63/67MM | In distribution |
| 11-146780 | 20MM 79/83MM | In distribution |
| 145153 | 70MM | In distribution |
| 145411 | 60MM | In distribution |
| 11-146512 | 12MM 59MM | In distribution |
| 11-146598 | 18MM 87/91MM | In distribution |
| 11-146756 | 16MM 71/75MM | In distribution |
| 11-146550 | 10MM 71/75MM | In distribution |
| 11-146742 | 22MM 63/67MM | In distribution |
| 11-146718 | 18MM 59MM | In distribution |
| 11-146552 | 12MM 71/75MM | In distribution |
| 145150 | 55MM | In distribution |
| 11-146378 | 18MM 79/83MM | In distribution |
| 11-146330 | 10MM 63/67MM | In distribution |
| 11-146178 | 18MM 79/83MM | In distribution |
| 145155 | 80MM | In distribution |
| 11-146134 | 14MM 63/67MM | In distribution |
| 11-146516 | 16MM 59MM | In distribution |
| 11-146170 | 10MM 79/83MM | In distribution |
| 11-146318 | 18MM 59MM | In distribution |
| 11-146132 | 12MM 63/67MM | In distribution |
| 145355 | 10MM 80MM | In distribution |
| 11-146324 | 24MM 59MM | In distribution |
| 11-146540 | 20MM 63/67MM | In distribution |
| 145150 | 55MM | In distribution |
| 11-146196 | 16MM 87/91MM | In distribution |
| 11-146804 | 24MM 87/91MM | In distribution |
| 11-146544 | 24MM 63/67MM | In distribution |
| 145431 | 60MM | In distribution |
| 11-146754 | 14MM 71/75MM | In distribution |
| 11-146596 | 16MM 87/91MM | In distribution |
| 145432 | 65MM | In distribution |
| 11-146338 | 18MM 63/67MM | In distribution |
| 145174 | 75MM | In distribution |
| 11-146130 | 10MM 63/67MM | In distribution |
| 11-146320 | 20MM 59MM | In distribution |
| 11-146592 | 12MM 87/91MM | In distribution |
| 11-146350 | 10MM 71/75MM | In distribution |
| 145435 | 80MM | In distribution |
| 11-146334 | 14MM 63/67MM | In distribution |
| 11-146384 | 24MM 79/83MM | In distribution |
| 11-146772 | 12MM 79/83MM | In distribution |
| 11-146332 | 12MM 63/67MM | In distribution |
| 11-146114 | 14MM 59MM | In distribution |
| 11-146590 | 10MM 87/91MM | In distribution |
| 11-146712 | 12MM 59MM | In distribution |
| 11-146312 | 12MM 59MM | In distribution |
| 145433 | 70MM | In distribution |
| 11-146138 | 18MM 63/67MM | In distribution |
| 11-146530 | 10MM 63/67MM | In distribution |
| 145410 | 55MM | In distribution |
| 11-146372 | 12MM 79/83MM | In distribution |
| 11-146340 | 20MM 63/67MM | In distribution |
| 11-146390 | 10MM 87/91MM | In distribution |
| 145151 | 60MM | In distribution |
| 11-146520 | 20MM 59MM | In distribution |
| 11-146364 | 24MM 71/75MM | In distribution |
| 11-146764 | 24MM 71/75MM | In distribution |
| 145414 | 75MM | In distribution |
| 145173 | 70MM | In distribution |
| 11-146720 | 20MM 59MM | In distribution |
| 145410 | 55MM | In distribution |
| 11-146760 | 20MM 71/75MM | In distribution |
| 11-146374 | 14MM 79/83MM | In distribution |
| 145199 | 65/80 MM | In distribution |
| 11-146198 | 18MM 87/91MM | In distribution |
| 11-146562 | 22MM 71/75MM | In distribution |
| 11-146380 | 20MM 79/83MM | In distribution |
| 145170 | 55MM | In distribution |
| 11-146522 | 22MM 59MM | In distribution |
| 11-146532 | 12MM 63/67MM | In distribution |
| 11-146392 | 12MM 87/91MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vanguard XP® Instrumentation | Biomet Orthopedics | 130 |
| Vanguard Complete Knee System | Biomet Orthopedics | 106 |
| Vanguard® 360 Instrument | Biomet Orthopedics | 98 |
| Biomet® Knee System | Biomet Orthopedics | 94 |
| 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
10 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 | 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 | 2018-05-24 | 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 | 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 | 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 | 2011-03-03 | Not classified | Packaging process control | The firm is recalling the product due to the product’s packaging being labeled “I-Beam 75mm. Tibial Plate”, but the package actually contains the “Interlok 67mm. CR Tibial Plate”. | 8 | 2011-07-27 |
| Biomet, Inc. | 510(k) number | 2007-12-12 | Not classified | Packaging process control | Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa. | 8 | 2008-06-11 |
| Biomet, Inc. | 510(k) number | 2007-12-12 | Not classified | Packaging process control | Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa. | 8 | 2008-06-11 |
| Biomet, Inc. | 510(k) number | 2007-09-18 | Not classified | Labeling mix-ups | Mislabeled as to size: the package actaully contained a 71 mm tray. | 7 | 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.