Sigma
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT UNICONDYLAR ALL POLYETHYLENE SIZE 6 11mm RM/LL XLK
7manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | KRR |
| Device type | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3540 |
| 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 |
|---|---|---|
| 1024-12-611 | In distribution | |
| 1024-12-511 | In distribution | |
| 1024-11-611 | In distribution | |
| 1024-11-311 | In distribution | |
| 1024-03-100 | In distribution | |
| 1024-11-210 | In distribution | |
| 1024-11-511 | In distribution | |
| 1024-11-411 | In distribution | |
| 1024-12-210 | In distribution | |
| 1024-11-610 | In distribution | |
| 1024-12-409 | In distribution | |
| 1024-12-411 | In distribution | |
| 1024-11-211 | In distribution | |
| 1024-03-300 | In distribution | |
| 1024-11-509 | In distribution | |
| 1024-11-609 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 103 |
| Restoris | Mako Surgical Corp. | 76 |
| Prelude Patello-Femoral System | Biomet Orthopedics | 61 |
| Prelude PF | Biomet Orthopedics | 59 |
| KneeTec PFJ | Corin Limited | 49 |
| HemiCAP® | Arthrosurface, Inc. | 48 |
| Instrument | Howmedica Osteonics Corp | 48 |
| Triathlon | Howmedica Osteonics Corp | 23 |
| Prelude PF | Biomet Sports Medicine | 21 |
| WaveKahuna™ | Arthrosurface, Inc. | 16 |
| HemiCAPWAVE® | Arthrosurface, Inc. | 16 |
| Restoris Esyntial | Mako Surgical Corp. | 14 |
Showing 12 of 47. All products under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, 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.