Polarstem
POLARSTEM COLLAR STANDARD NON-CEMENTED WITH Ti/HA 10
14manufacturers in China registered for this device type
17catalogue numbers in this listing
13510(k) clearances naming this product code
5recalls 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 | Smith & Nephew, Inc., United States |
|---|---|
| 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, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K143739 |
| Record published | 2016-07-25 |
| Record revised | 2025-07-15 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 75018409 | In distribution | |
| 75018410 | In distribution | |
| 75102074 | In distribution | |
| 75018407 | In distribution | |
| 75018408 | In distribution | |
| 75102241 | In distribution | |
| 75018415 | In distribution | |
| 75018418 | In distribution | |
| 75018419 | In distribution | |
| 75102251 | In distribution | |
| 75102075 | In distribution | |
| 75018405 | In distribution | |
| 75102259 | In distribution | |
| 75102210 | In distribution | |
| 75102072 | In distribution | |
| 75102252 | In distribution | |
| 75102211 | 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 |
|---|---|
| K162303 | 2017-05-01 |
| K121627 | 2012-10-15 |
| K113039 | 2012-10-05 |
| K113789 | 2012-04-19 |
| K100481 | 2010-07-15 |
| K090982 | 2010-04-21 |
| K081124 | 2008-07-31 |
| K052426 | 2005-12-07 |
| K042127 | 2004-11-19 |
| K040680 | 2004-06-14 |
| K023302 | 2002-10-25 |
| K002996 | 2000-12-11 |
| K990666 | 1999-08-06 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2024-10-15 | Class II | Under Investigation by firm | The Bipolar assembly contains an oversized Retainer Ring. | 21 devices | |
| Smith & Nephew Orthopaedics AG | 510(k) number | 2020-07-22 | Class II | Device Design | Multiple lots being recalled due to a product design issue | 528 unit | 2026-08-21 |
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2016-11-15 | Class II | Device Design | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. | 6266 units | 2019-08-19 |
| 2016-11-15 | Class II | Device Design | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. | 11999 units | 2019-08-19 |
| 2016-11-15 | Class II | Device Design | All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend. | 13671 units | 2019-08-19 |
| 2016-07-06 | Class II | Packaging process control | The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw. | 185 units | 2017-07-01 |
| 2012-08-22 | Class II | Employee error | Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. | 70 units | 2013-02-27 |
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.