Lima PSI
Lima CT RSA guide and bone model
9manufacturers in China registered for this device type
14catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 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 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Materialise NV, Belgium |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K153602 |
| Record published | 2017-07-21 |
| Record revised | 2024-08-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2017-07-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHC-LM02-02-01 | In distribution | |
| SHC-LM01-00-01 | In distribution | |
| SHC-LM01-02-01 | In distribution | |
| SHC-LM02-00-01 | In distribution | |
| SHC-LM02-01-01 | In distribution | |
| SHC-LM10-00-01 | In distribution | |
| SHC-LM01-01-01 | In distribution | |
| SHC-LM01-01-01 | Withdrawn | |
| SHC-LM01-00-01 | Withdrawn | |
| SHC-LM01-02-01 | Withdrawn | |
| SHC-LM02-00-01 | Withdrawn | |
| SHC-LM10-00-01 | Withdrawn | |
| SHC-LM02-01-01 | Withdrawn | |
| SHC-LM02-02-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190286 | 2019-07-08 |
| K172054 | 2017-11-03 |
| K170893 | 2017-06-19 |
| K153602 | 2016-04-26 |
| K131559 | 2013-09-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Materialise N.V. | 510(k) number | 2020-07-17 | Class II | Software Design Change | The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as “Left” for surgical plans for a “right” procedure side. | 128 | 2020-12-23 |
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.