Guardian®
GUARDIAN® STRAIGHT STEM 15mm X 152mm TTnm. w/POROUS COLLAR
7manufacturers in China registered for this device type
46catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), 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 |
|---|---|---|---|---|
| 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 |
| 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 | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-22 |
| Record revised | 2020-04-20 (version 3) |
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, manufacturing date |
| Sizes | Length 120 to 152 mm; height 8 to 20 mm; outer diameter 40 to 140 mm; length 120 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25001220 | Height 20 mm | In distribution |
| 2500CP16 | Length 152 mm | In distribution |
| 25002200 | In distribution | |
| 2500SP16 | Length 120 mm | In distribution |
| 25000051 | Outer Diameter 50 mm | In distribution |
| 2500BP22 | Length 152 mm | In distribution |
| 25002113 | In distribution | |
| 25002111 | In distribution | |
| 2500L004 | In distribution | |
| 2500BP18 | Length 152 mm | In distribution |
| 25000015 | Length 152 mm | In distribution |
| 25000216 | Height 16 mm | In distribution |
| 25003009 | Length 120 µm | In distribution |
| 25002201 | In distribution | |
| 25001040 | Outer Diameter 40 mm | In distribution |
| 25001090 | Outer Diameter 90 mm | In distribution |
| 25003013 | Length 120 mm | In distribution |
| 25009017 | Length 152 mm | In distribution |
| 25002101 | In distribution | |
| 25008015 | Length 152 mm | In distribution |
| 25004011 | Length 120 mm | In distribution |
| 25001060 | Outer Diameter 60 mm | In distribution |
| 25002205 | In distribution | |
| 25001208 | Height 8 mm | In distribution |
| 25000011 | Length 152 mm | In distribution |
| 2500SP12 | Length 120 mm | In distribution |
| 25000071 | Outer Diameter 70 mm | In distribution |
| 2500L002 | In distribution | |
| 25000212 | Height 12 mm | In distribution |
| 25001015 | Length 152 mm | In distribution |
| 25000009 | In distribution | |
| 25001212 | Height 12 mm | In distribution |
| 25001140 | Outer Diameter 140 mm | In distribution |
| 25000210 | Height 10 mm | In distribution |
| 25000208 | Height 8 mm | In distribution |
| 25002203 | In distribution | |
| 25000017 | Length 152 mm | In distribution |
| 2500BP14 | Length 152 mm | In distribution |
| 2500SP20 | Length 120 mm | In distribution |
| 2500R003 | In distribution | |
| 25002010 | In distribution | |
| 2500CC15 | Length 152 mm | In distribution |
| 2500CP12 | Length 152 mm | In distribution |
| 25000111 | Outer Diameter 110 mm | In distribution |
| 2500CC11 | Length 152 mm | In distribution |
| 25000220 | Height 20 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240043 | 2024-04-01 |
| K230563 | 2023-09-27 |
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.