Alpine Hip System
EXT Size 16 Stem Press-Fit
5manufacturers in China registered for this device type
6catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 4 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Ortho Development Corp., United States |
|---|---|
| FDA product code | MBL |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K141001 |
| Record published | 2015-08-31 |
| Record revised | 2018-07-06 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700-1016 | In distribution | |
| 700-1019 | In distribution | |
| 700-0010 | In distribution | |
| 700-0013 | In distribution | |
| 700-1011 | In distribution | |
| 700-1017 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 100 |
| Reflection | Smith & Nephew, Inc. | 89 |
| Profemur® | Microport Orthopedics Inc. | 53 |
| Delta | Limacorporate | 44 |
| Onvoy | Globus Medical, Inc. | 40 |
| Restoration | Howmedica Osteonics Corp | 39 |
| Dynasty | Microport Orthopedics Inc. | 28 |
| Delta Liners & Accessories | Limacorporate | 27 |
| R3, Stiktite | Smith & Nephew, Inc. | 26 |
| Biolox Delta | Limacorporate | 19 |
| Tri-plus | Ortho Development Corp. | 16 |
Showing 12 of 96. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-05-10 | Not classified | Package design/selection | Tests on PVC packaging material resulted in alert levels for cytotoxicity. | 113 units | 2011-11-09 |
| 2011-05-10 | Not classified | Package design/selection | Tests on PVC packaging material resulted in alert levels for cytotoxicity. | 113 units | 2011-11-09 |
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.