Maxim Knee System
172 catalogue numbers from 145431, 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
172catalogue 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) | K033489 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 145431 | 60MM | In distribution |
| RD145611 | 60MM | In distribution |
| 145132 | 65MM | In distribution |
| 11-146784 | 24MM 79/83MM | In distribution |
| 140030 | 55MM | In distribution |
| 145134 | 75MM | In distribution |
| 145155 | 80MM | In distribution |
| 140031 | 60MM | In distribution |
| 145375 | 10MM 80MM | In distribution |
| 140013 | 70MM | In distribution |
| 140033 | 70MM | In distribution |
| 11-146750 | 10MM 71/75MM | In distribution |
| 145154 | 75MM | In distribution |
| CP102745 | 12 MM 80 MM | In distribution |
| 145341 | 6MM 60MM | In distribution |
| 11-146194 | 14MM 87/91MM | In distribution |
| 11-146152 | 12MM 71/75MM | In distribution |
| 140031 | 60MM | In distribution |
| 145112 | 65MM | In distribution |
| 145135 | 80MM | In distribution |
| CP110188 | 70 MM | In distribution |
| 145372 | 10MM 65MM | In distribution |
| 11-146336 | 16MM 63/67MM | In distribution |
| RD145632 | 65MM | In distribution |
| 140052 | 65MM | In distribution |
| 145113 | 70MM | In distribution |
| 145332 | 6MM 65MM | In distribution |
| 140034 | 75MM | In distribution |
| 11-146314 | 14MM 59MM | In distribution |
| 145134 | 75MM | In distribution |
| 11-146360 | 20MM 71/75MM | In distribution |
| 11-146710 | 10MM 59MM | In distribution |
| 145361 | 10MM 60MM | In distribution |
| 11-146534 | 14MM 63/67MM | In distribution |
| 11-146730 | 10MM 63/67MM | In distribution |
| 145115 | 80MM | In distribution |
| CP110648 | 14 MM 430 MM | In distribution |
| 140012 | 65MM | In distribution |
| 145133 | 70MM | In distribution |
| CP102953 | 20 MM 63/67 MM | In distribution |
| 145350 | 10MM 55MM | In distribution |
| 145382 | 10MM 65MM | In distribution |
| 145324 | 6MM 75MM | In distribution |
| 145322 | 6MM 65MM | In distribution |
| 145386 | 6MM | In distribution |
| CP102759 | 20 MM 120 MM | In distribution |
| 145384 | 10MM 75MM | In distribution |
| 11-146574 | 14MM 79/83MM | In distribution |
| 145312 | 6MM 65MM | In distribution |
| 145434 | 75MM | In distribution |
| 140051 | 60MM | In distribution |
| 145353 | 10MM 70MM | In distribution |
| 145331 | 6MM 60MM | In distribution |
| 145154 | 75MM | In distribution |
| CP102744 | 10 MM 80 MM | In distribution |
| CP110192 | 70 MM | In distribution |
| 145314 | 6MM 75MM | In distribution |
| 145112 | 65MM | In distribution |
| CP110647 | 14 MM 400 MM | In distribution |
| 11-146336 | 16MM 63/67MM | In distribution |
| 11-146798 | 18MM 87/91MM | In distribution |
| 145352 | 10MM 65MM | In distribution |
| 145111 | 60MM | In distribution |
| CP110191 | 65 MM | In distribution |
| 145380 | 10MM 55MM | In distribution |
| 140055 | 80MM | In distribution |
| 145340 | 6MM 55MM | In distribution |
| 145385 | 10MM 80MM | In distribution |
| 140052 | 65MM | In distribution |
| 145113 | 70MM | In distribution |
| 140010 | 55MM | In distribution |
| 145383 | 10MM 70MM | In distribution |
| RD145613 | 70MM | In distribution |
| 145370 | 10MM 55MM | In distribution |
| CP110646 | 14 MM 370 MM | In distribution |
| 145381 | 10MM 60MM | In distribution |
| 145321 | 6MM 60MM | In distribution |
| 140011 | 60MM | In distribution |
| CP102756 | 14 MM 120 MM | In distribution |
| CP102754 | 10 MM 120 MM | In distribution |
| 140030 | 55MM | In distribution |
| 145360 | 10MM 55MM | In distribution |
| 145333 | 6MM 70MM | In distribution |
| 145311 | 6MM 60MM | In distribution |
| 145131 | 60MM | In distribution |
| RD145612 | 65MM | In distribution |
| 145313 | 6MM 70MM | In distribution |
| 11-146776 | 16MM 79/83MM | In distribution |
| 11-146558 | 18MM 71/75MM | In distribution |
| 145114 | 75MM | In distribution |
| 145351 | 10MM 60MM | In distribution |
| 140012 | 65MM | In distribution |
| 11-146582 | 22MM 79/83MM | In distribution |
| 140051 | 60MM | In distribution |
| 145170 | 55MM | In distribution |
| 145133 | 70MM | In distribution |
| 145130 | 55MM | In distribution |
| 145175 | 80MM | In distribution |
| 140033 | 70MM | In distribution |
| 11-146310 | 10MM 59MM | In distribution |
| 145111 | 60MM | In distribution |
| CP102758 | 18 MM 120 MM | In distribution |
| CP102748 | 18 MM 80 MM | In distribution |
| 145323 | 6MM 70MM | In distribution |
| 11-146332 | 12MM 63/67MM | In distribution |
| 11-146602 | 22MM 87/91MM | In distribution |
| 140053 | 70MM | In distribution |
| 11-146560 | 20MM 71/75MM | In distribution |
| 145432 | 65MM | In distribution |
| 11-146796 | 16MM 87/91MM | In distribution |
| 11-146394 | 14MM 87/91MM | In distribution |
| 145365 | 10MM 80MM | In distribution |
| 140035 | 80MM | In distribution |
| 145364 | 10MM 75MM | In distribution |
| 145435 | 80MM | In distribution |
| 145430 | 55MM | In distribution |
| 145130 | 55MM | In distribution |
| 145131 | 60MM | In distribution |
| 145114 | 75MM | In distribution |
| 145110 | 55MM | In distribution |
| 11-146584 | 24MM 79/83MM | In distribution |
| 140035 | 80MM | In distribution |
| 145354 | 10MM 75MM | In distribution |
| 145135 | 80MM | In distribution |
| 145320 | 6MM 55MM | In distribution |
| 11-146190 | 10MM 87/91MM | In distribution |
| 11-146790 | 10MM 87/91MM | In distribution |
| 145342 | 6MM 65MM | In distribution |
| 145343 | 6MM 70MM | In distribution |
| 145335 | 6MM 80MM | In distribution |
| 145344 | 6MM 75MM | In distribution |
| 145315 | 6MM 80MM | In distribution |
| 11-146600 | 20MM 87/91MM | In distribution |
| 11-146782 | 22MM 79/83MM | In distribution |
| 145374 | 10MM 75MM | In distribution |
| 145310 | 6MM 55MM | In distribution |
| 11-146154 | 14MM 71/75MM | In distribution |
| CP102957 | 22 MM 71/75 MM | In distribution |
| CP102956 | 20 MM 71/75 MM | In distribution |
| 11-146556 | 16MM 71/75MM | In distribution |
| 11-146580 | 20MM 79/83MM | In distribution |
| 145325 | 6MM 80MM | In distribution |
| 145371 | 10MM 60MM | In distribution |
| RD145631 | 60MM | In distribution |
| 11-146344 | 24MM 63/67MM | In distribution |
| CP102749 | 20 MM 80 MM | In distribution |
| 140013 | 70MM | In distribution |
| 145362 | 10MM 65MM | In distribution |
| 11-146774 | 14MM 79/83MM | In distribution |
| 145415 | 80MM | In distribution |
| 145115 | 80MM | In distribution |
| CP110186 | 60 MM | In distribution |
| 140034 | 75MM | In distribution |
| 145110 | 55MM | In distribution |
| 145373 | 10MM 70MM | In distribution |
| CP110190 | 60 MM | In distribution |
| 145363 | 10MM 70MM | In distribution |
| 140014 | 75MM | In distribution |
| 140032 | 65MM | In distribution |
| 145415 | 80MM | In distribution |
| 140015 | 80MM | In distribution |
| 145345 | 6MM 80MM | In distribution |
| 140015 | 80MM | In distribution |
| 140014 | 75MM | In distribution |
| 145132 | 65MM | In distribution |
| 145330 | 6MM 55MM | In distribution |
| 145334 | 6MM 75MM | In distribution |
| 140011 | 60MM | In distribution |
| 11-146192 | 12MM 87/91MM | In distribution |
| 140032 | 65MM | In distribution |
| RD145633 | 70MM | In distribution |
| 140010 | 55MM | 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
13 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 | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 54 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. | 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 |
| Biomet, Inc. | 510(k) number | 2007-07-24 | Not classified | Labeling mix-ups | Incorrect Product — Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm. | 4 | 2008-07-24 |
| Biomet, Inc. | 510(k) number | 2007-07-24 | Not classified | Labeling mix-ups | Incorrect Product — Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm. | 1 | 2008-07-24 |
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.