Iuni Ipoly Implant
IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or medial
6manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (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 |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | ConforMIS, Inc., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K111916 |
| Record published | 2022-08-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UKA-111-111103 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132640 | 2013-12-05 |
| K121974 | 2012-09-06 |
| K111916 | 2011-09-29 |
| K092441 | 2009-09-09 |
| K072586 | 2007-11-08 |
| K072368 | 2007-09-20 |
| K063432 | 2007-03-16 |
| K043570 | 2005-03-14 |
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 |
|---|---|---|---|---|---|
| 2009-04-23 | Not classified | Process control | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. | 6 units | 2009-10-14 |
| 2009-04-23 | Not classified | Process control | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. | 1 unit | 2009-10-14 |
| 2009-04-23 | Not classified | Process control | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. | 10 Units | 2009-10-14 |
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.