Journey
Journey Deuce Femoral Cocr Size 4 Right
3manufacturers in China registered for this device type
24catalogue numbers in this listing
4510(k) clearances naming this product 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 | Smith & Nephew, 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 | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K052265 |
| Record published | 2015-09-28 |
| Record revised | 2023-09-07 (version 4) |
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 |
| Distribution end date | 2016-01-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71422906 | Withdrawn | |
| 71422205 | Withdrawn | |
| 71422904 | Withdrawn | |
| 71422914 | Withdrawn | |
| 71422216 | Withdrawn | |
| 71422918 | Withdrawn | |
| 71422913 | Withdrawn | |
| 71422908 | Withdrawn | |
| 71422213 | Withdrawn | |
| 71422917 | Withdrawn | |
| 71422203 | Withdrawn | |
| 71422204 | Withdrawn | |
| 71422907 | Withdrawn | |
| 71422903 | Withdrawn | |
| 71422214 | Withdrawn | |
| 71422206 | Withdrawn | |
| 71422916 | Withdrawn | |
| 71422915 | Withdrawn | |
| 71422905 | Withdrawn | |
| 71422218 | Withdrawn | |
| 71422207 | Withdrawn | |
| 71422208 | Withdrawn | |
| 71422217 | Withdrawn | |
| 71422215 | Withdrawn |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 |
| 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 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 |
|---|---|
| K093056 | 2009-12-15 |
| K061569 | 2006-07-06 |
| K052265 | 2005-12-27 |
| K042896 | 2005-01-12 |
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.