Iduo® Patella Sizer
iDuo® 35mm Patella Sizer Reusable Instrument
3manufacturers in China registered for this device type
3catalogue 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) | K133256 |
| Record published | 2016-10-24 |
| Record revised | 2023-05-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 35 to 41 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1080-408 | Outer Diameter 35 mm | In distribution |
| 1080-410 | Outer Diameter 41 mm | In distribution |
| 1080-409 | Outer Diameter 38 mm | In distribution |
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 |
| iDuo® iPoly™ Insert Kit | ConforMIS, Inc. | 15 |
| 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 | 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.