Guardian®
GUARDIAN® STRAIGHT STEM 11mm X 152mm TTnm. w/POROUS COLLAR
13manufacturers in China registered for this device type
36catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 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; outer diameter 40 to 140 mm; height 10 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2500CC13 | Length 152 mm | In distribution |
| 25002110 | In distribution | |
| 25008013 | Length 152 mm | In distribution |
| 25001070 | Outer Diameter 70 mm | In distribution |
| 2500CC17 | Length 152 mm | In distribution |
| 2500SP22 | Length 120 mm | In distribution |
| 2500SP18 | Length 120 mm | In distribution |
| 25004013 | Length 120 mm | In distribution |
| 25001210 | Height 10 mm | In distribution |
| 25001011 | Length 152 mm | In distribution |
| 25000041 | Outer Diameter 40 mm | In distribution |
| 25001050 | Outer Diameter 50 mm | In distribution |
| 25002114 | In distribution | |
| 25000141 | Outer Diameter 140 mm | In distribution |
| 2500R002 | In distribution | |
| 25003011 | Length 120 mm | In distribution |
| 25002112 | In distribution | |
| 25002100 | In distribution | |
| 25000007 | In distribution | |
| 2500CP14 | Length 152 mm | In distribution |
| 25000091 | Outer Diameter 90 mm | In distribution |
| 2500BP12 | Length 152 mm | In distribution |
| 25004009 | Length 120 mm | In distribution |
| 25002202 | In distribution | |
| 25002204 | In distribution | |
| 2500BP20 | Length 152 mm | In distribution |
| 2500SP14 | Length 120 mm | In distribution |
| 25008017 | Length 152 mm | In distribution |
| 25000061 | Outer Diameter 60 mm | In distribution |
| 25000001 | In distribution | |
| 2500L003 | In distribution | |
| 25000013 | Length 152 mm | In distribution |
| 2500BP16 | Length 152 mm | In distribution |
| 25001216 | Height 16 mm | In distribution |
| 2500R004 | In distribution | |
| 25001110 | Outer Diameter 110 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213816 | 2022-01-05 |
| K201519 | 2020-12-10 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-05-04 | Class II | Process change control | One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. | 8 units | 2024-01-16 |
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.