Iuni® Femoral Kit
2 catalogue numbers from RUK101111203, listed by ConforMIS, Inc., United States, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product 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) | K132640 |
| Record published | 2015-10-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RUK101111203 | Patient Specific | In distribution |
| RUK101111202 | Patient Specific | 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 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 |
|---|---|---|---|---|---|---|---|
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 7 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 71 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 6 units | 2016-03-02 |
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.