Sigma
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT UNICONDYLAR ALL POLYETHYLENE SIZE 3 10mm LM/RL XLK
3manufacturers in China registered for this device type
64catalogue numbers in this listing
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 | Depuy (Ireland), Ireland |
|---|---|
| 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K061648 |
| Record published | 2015-09-24 |
| Record revised | 2024-12-09 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1024-12-108 | In distribution | |
| 1024-52-100 | In distribution | |
| 1024-07-300 | In distribution | |
| 1024-53-507 | In distribution | |
| 1024-51-100 | In distribution | |
| 1024-54-508 | In distribution | |
| 1024-54-607 | In distribution | |
| 1024-11-108 | In distribution | |
| 1024-54-311 | In distribution | |
| 1024-08-100 | In distribution | |
| 1024-52-600 | In distribution | |
| 1024-07-500 | In distribution | |
| 1024-12-608 | In distribution | |
| 1024-54-207 | In distribution | |
| 1024-54-507 | In distribution | |
| 1024-53-411 | In distribution | |
| 1024-53-107 | In distribution | |
| 1024-54-509 | In distribution | |
| 1024-11-408 | In distribution | |
| 1024-53-608 | In distribution | |
| 1024-11-310 | In distribution | |
| 1024-53-607 | In distribution | |
| 1024-51-600 | In distribution | |
| 1024-12-508 | In distribution | |
| 1024-53-311 | In distribution | |
| 1024-04-400 | In distribution | |
| 1024-54-310 | In distribution | |
| 1024-03-200 | In distribution | |
| 1024-07-400 | In distribution | |
| 1024-04-300 | In distribution | |
| 1024-54-109 | In distribution | |
| 1024-53-510 | In distribution | |
| 1024-04-100 | In distribution | |
| 1024-54-307 | In distribution | |
| 1024-51-300 | In distribution | |
| 1024-53-409 | In distribution | |
| 1024-53-508 | In distribution | |
| 1024-53-610 | In distribution | |
| 1024-08-500 | In distribution | |
| 1024-53-609 | In distribution | |
| 1024-11-510 | In distribution | |
| 1024-51-400 | In distribution | |
| 1024-53-408 | In distribution | |
| 1024-54-210 | In distribution | |
| 1024-53-207 | In distribution | |
| 1024-04-200 | In distribution | |
| 1024-03-500 | In distribution | |
| 1024-53-308 | In distribution | |
| 1024-12-311 | In distribution | |
| 1024-54-407 | In distribution | |
| 1024-53-511 | In distribution | |
| 1024-11-308 | In distribution | |
| 1024-54-609 | In distribution | |
| 1024-12-209 | In distribution | |
| 1024-12-109 | In distribution | |
| 1024-51-200 | In distribution | |
| 1024-54-208 | In distribution | |
| 1024-12-309 | In distribution | |
| 1024-53-109 | In distribution | |
| 1024-12-610 | In distribution | |
| 1024-51-500 | In distribution | |
| 1024-54-409 | In distribution | |
| 1024-12-410 | In distribution | |
| 1024-12-510 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Restoris | Mako Surgical Corp. | 101 |
| 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 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2017-12-21 | Class II | Under Investigation by firm | The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process. | 2110 | 2020-04-01 |
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.