MultiPolar®
100 catalogue numbers from 5001-53-28, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
100catalogue numbers in this listing
5510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K833991 |
| Record published | 2022-02-25 |
| Record revised | 2020-09-09 (version 5) |
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 |
| Sizes | Lumen/inner diameter 22 to 32 mm; outer diameter 38 to 72 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5001-53-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-60 | Outer Diameter 60 mm | In distribution |
| 5001-58 | Outer Diameter 58 mm | In distribution |
| 5001-72-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-64-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 5001-60-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-60-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-53-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-68-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-57-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-50-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-39 | Outer Diameter 39 mm | In distribution |
| 5001-47-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 5001-50-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-55 | Outer Diameter 55 mm | In distribution |
| 5001-40 | Outer Diameter 40 mm | In distribution |
| 5001-40-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-50-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-49 | Outer Diameter 49 mm | In distribution |
| 5001-68-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-44-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-53-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-44-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-52 | Outer Diameter 52 mm | In distribution |
| 5001-47-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-40-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-53-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-50-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-39-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-57 | Outer Diameter 57 mm | In distribution |
| 5001-47 | Outer Diameter 47 mm | In distribution |
| 5001-53-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-47-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-47-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-40-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-72-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-53-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-70 | Outer Diameter 70 mm | In distribution |
| 5001-66 | Outer Diameter 66 mm | In distribution |
| 5001-68-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-48 | Outer Diameter 48 mm | In distribution |
| 5001-47-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-60-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-41 | Outer Diameter 41 mm | In distribution |
| 5001-50-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-68 | Outer Diameter 68 mm | In distribution |
| 5001-60-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-50-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-64-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-40-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-54 | Outer Diameter 54 mm | In distribution |
| 5001-46 | Outer Diameter 46 mm | In distribution |
| 5001-50-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 5001-72 | Outer Diameter 72 mm | In distribution |
| 5001-42-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-43 | Outer Diameter 43 mm | In distribution |
| 5001-44-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-68-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-60-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-68-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-47-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-72-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-47-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-42-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-64 | Outer Diameter 64 mm | In distribution |
| 5001-42 | Outer Diameter 42 mm | In distribution |
| 5001-38 | Outer Diameter 38 mm | In distribution |
| 5001-38-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-50 | Outer Diameter 50 mm | In distribution |
| 5001-38-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-51 | Outer Diameter 51 mm | In distribution |
| 5001-57-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-42-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-60-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-57-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 5001-64-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-57-22 | Lumen/Inner Diameter 22.00 mm | In distribution |
| 5001-57-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-53-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-64-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-44-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-64-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-60-28 | Lumen/Inner Diameter 28.00 mm | In distribution |
| 5001-44-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-57-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 5001-53-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 5001-64-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 5001-50-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-45 | Outer Diameter 45 mm | In distribution |
| 5001-44-26 | Lumen/Inner Diameter 26 mm | In distribution |
| 5001-42-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-47-26 | Lumen/Inner Diameter 26.00 mm | In distribution |
| 5001-62 | Outer Diameter 62 mm | In distribution |
| 5001-68-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 5001-44 | Outer Diameter 44 mm | In distribution |
| 5001-60-32 | Lumen/Inner Diameter 32.00 mm | In distribution |
| 5001-53 | Outer Diameter 53 mm | In distribution |
| 5001-39-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-57-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 5001-57-26 | Lumen/Inner Diameter 26 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
| Corin BiPolar-i | Corin Limited | 54 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192236 | 2019-11-05 |
| K170072 | 2017-02-07 |
| K884658 | 1988-11-30 |
| K872019 | 1987-07-21 |
| K833991 | 1984-01-30 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 72806 | 2017-05-23 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 8773 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-08-30 | Class II | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | 72806 | 2014-09-25 |
| Zimmer, Inc. | 510(k) number | 2012-08-31 | Class II | Process design | Zimmer Inc. is initiating a removal of the Multipolar Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled. | 195 | 2013-09-23 |
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.