Vanguard M Partial Knee System
54 catalogue numbers from US154708, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
54catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| 510(k) | K021621 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| US154708 | B8 | In distribution |
| US154713 | C5 | In distribution |
| US154700 | B4 | In distribution |
| US154707 | B7 | In distribution |
| US154720 | D4 | In distribution |
| US154600 | SMALL SIZE | In distribution |
| US154748 | A8 | In distribution |
| US154704 | B6 | In distribution |
| US154742 | A5 | In distribution |
| US154741 | A4 | In distribution |
| US154738 | E8 | In distribution |
| US154723 | D5 | In distribution |
| US154721 | D4 | In distribution |
| US154745 | A6 | In distribution |
| US154715 | C6 | In distribution |
| US154601 | MEDIUM SIZE | In distribution |
| US154722 | D5 | In distribution |
| US154724 | D6 | In distribution |
| US154747 | A7 | In distribution |
| US154602 | LARGE SIZE | In distribution |
| US154740 | A4 | In distribution |
| US154743 | A5 | In distribution |
| US154703 | B5 | In distribution |
| US154717 | C7 | In distribution |
| US154714 | C6 | In distribution |
| US154719 | C8 | In distribution |
| US154731 | E4 | In distribution |
| US154727 | D7 | In distribution |
| US154737 | E7 | In distribution |
| US154710 | C4 | In distribution |
| US154712 | C5 | In distribution |
| US154730 | E4 | In distribution |
| US154726 | D7 | In distribution |
| US154732 | E5 | In distribution |
| US154706 | B7 | In distribution |
| US154716 | C7 | In distribution |
| US154736 | E7 | In distribution |
| US154733 | E5 | In distribution |
| US154711 | C4 | In distribution |
| US154734 | E6 | In distribution |
| US154744 | A6 | In distribution |
| US154746 | A7 | In distribution |
| US154718 | C8 | In distribution |
| US154702 | B5 | In distribution |
| US154749 | A8 | In distribution |
| US154729 | D8 | In distribution |
| US154728 | D8 | In distribution |
| US154603 | X-LARGE SIZE | In distribution |
| US154705 | B6 | In distribution |
| US154701 | B4 | In distribution |
| US154739 | E8 | In distribution |
| US154709 | B8 | In distribution |
| US154725 | D6 | In distribution |
| US154735 | E6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020264 | 2002-02-08 |
Recalls Naming This Product
3 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 | 105 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2015-04-22 | Class II | Process control | The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel | 27 | 2016-03-22 |
| Biomet UK Ltd. | 510(k) number | 2011-04-22 | Not classified | Packaging | This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device. | 12 devices | 2011-08-03 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.