Iduo® Ipoly™ Insert Kit
IDUO IPOLY 11MM INSERT KIT LEFT or right MEDIAL or lateral
3manufacturers in China registered for this device type
15catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1). 3 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 |
Record
| Listed by | ConforMIS, Inc., United States |
|---|---|
| FDA product code | NPJ |
| Device type | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K053488 |
| Record published | 2015-10-26 |
| Record revised | 2022-08-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Height 6 to 14 mm |
| Distribution end date | 2022-08-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RBK010080001 | Height 8 mm | In distribution |
| RBK010100001 | Height 10 mm | In distribution |
| RBK010120002 | Height 12 mm | In distribution |
| RBK010140002 | Height 14 mm | In distribution |
| RBK010080002 | Height 8 mm | In distribution |
| RBK010110002 | Height 11 mm | In distribution |
| RBK010060002 | Height 6 mm | In distribution |
| RBK010130002 | Height 13 mm | In distribution |
| RBK010100002 | In distribution | |
| RBK010090002 | Height 9 mm | In distribution |
| RBK010090001 | Height 9 mm | Withdrawn |
| RBK010070001 | Height 7 mm | Withdrawn |
| RBK010120001 | Height 12 mm | Withdrawn |
| RBK010060001 | Height 6 mm | Withdrawn |
| RBK010110001 | Height 11 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Restoris | Mako Surgical Corp. | 101 |
| Sigma | Depuy (Ireland) | 64 |
| Instrument | Howmedica Osteonics Corp | 62 |
| Triathlon | Howmedica Osteonics Corp | 33 |
| Journey | Smith & Nephew, Inc. | 24 |
| Restoris Esyntial | Mako Surgical Corp. | 13 |
| Mako | Mako Surgical Corp. | 7 |
| Specialty Triathlon TS Trial Assessment Guide Size 8 Right | Howmedica Osteonics Corp | 6 |
| iDuo® Patella Trial | ConforMIS, Inc. | 4 |
| Unix | Howmedica Osteonics Corp | 3 |
| iDuo® Patella Sizer | ConforMIS, Inc. | 3 |
| iDuo® Patella | ConforMIS, Inc. | 2 |
Showing 12 of 21. All products under Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093513 | 2009-12-16 |
| K053488 | 2006-03-09 |
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 | 2016-03-02 | |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 12 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 1 unit | 2016-03-02 |
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.