Origin Hip Stem
40 catalogue numbers from D111-18-1803, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
40catalogue numbers in this listing
8510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Signature Orthopaedics PTY Limited, Australia |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161155 |
| Record published | 2022-09-20 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D111-18-1803 | In distribution | |
| D111-18-1200 | In distribution | |
| D111-18-1100 | In distribution | |
| D111-18-1203 | In distribution | |
| D111-18-0803 | In distribution | |
| D111-18-1403 | In distribution | |
| D111-18-1801 | In distribution | |
| D111-18-1303 | In distribution | |
| D111-18-0801 | In distribution | |
| D111-18-1001 | In distribution | |
| D111-18-1401 | In distribution | |
| D111-18-1103 | In distribution | |
| D111-18-1002 | In distribution | |
| D111-18-1201 | In distribution | |
| D111-18-1300 | In distribution | |
| D111-18-1000 | In distribution | |
| D111-18-1202 | In distribution | |
| D111-18-1101 | In distribution | |
| D111-18-0903 | In distribution | |
| D111-18-1603 | In distribution | |
| D111-18-1503 | In distribution | |
| D111-18-1302 | In distribution | |
| D111-18-1301 | In distribution | |
| D111-18-1600 | In distribution | |
| D111-18-1800 | In distribution | |
| D111-18-0802 | In distribution | |
| D111-18-1602 | In distribution | |
| D111-18-1501 | In distribution | |
| D111-18-0902 | In distribution | |
| D111-18-1102 | In distribution | |
| D111-18-1500 | In distribution | |
| D111-18-0901 | In distribution | |
| D111-18-1601 | In distribution | |
| D111-18-1802 | In distribution | |
| D111-18-1400 | In distribution | |
| D111-18-1003 | In distribution | |
| D111-18-1402 | In distribution | |
| D111-18-0900 | In distribution | |
| D111-18-0800 | In distribution | |
| D111-18-1502 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243162 | 2024-11-25 |
| K241690 | 2024-08-01 |
| K220495 | 2023-01-13 |
| K211742 | 2022-01-07 |
| K211505 | 2021-09-24 |
| K201278 | 2020-09-21 |
| K161155 | 2016-07-19 |
| K153131 | 2016-06-03 |
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 |
|---|---|---|---|---|---|---|---|
| Signature Orthopaedics PTY Limited | 510(k) number | 2021-04-20 | Class II | Labeling mix-ups | Product mislabeled, with the incorrect product inside the package. | 3 units | 2023-01-19 |
| Signature Orthopaedics Europe Ltd | 510(k) number | 2019-10-09 | Class II | Labeling Change Control | The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay. | 5 components | |
| Signature Orthopaedics PTY Limited | 510(k) number | 2018-02-02 | Class II | Labeling mix-ups | This recall has been identified due to the batch being mislabeled, with the packaged component’s size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resultin | 10 | 2018-08-08 |
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.