Sigma
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT UNICONDYLAR ALL POLYETHYLENE SIZE 1 10mm RM/LL XLK
10manufacturers in China registered for this device type
94catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K193549 |
| Record published | 2021-04-23 |
| Record revised | 2024-12-12 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1024-56-509 | In distribution | |
| 1024-54-309 | In distribution | |
| 1024-11-209 | In distribution | |
| 1024-54-111 | In distribution | |
| 1024-11-208 | In distribution | |
| 1024-52-500 | In distribution | |
| 1024-12-408 | In distribution | |
| 1024-56-507 | In distribution | |
| 1024-55-511 | In distribution | |
| 1024-56-607 | In distribution | |
| 1024-07-100 | In distribution | |
| 1024-55-210 | In distribution | |
| 1024-12-308 | In distribution | |
| 1024-12-110 | In distribution | |
| 1024-12-208 | In distribution | |
| 1024-56-311 | In distribution | |
| 1024-12-310 | In distribution | |
| 1024-11-508 | In distribution | |
| 1024-08-300 | In distribution | |
| 1024-56-409 | In distribution | |
| 1024-54-209 | In distribution | |
| 1024-56-211 | In distribution | |
| 1024-53-509 | In distribution | |
| 1024-53-110 | In distribution | |
| 1024-53-309 | In distribution | |
| 1024-08-200 | In distribution | |
| 1024-11-410 | In distribution | |
| 1024-56-208 | In distribution | |
| 1024-53-210 | In distribution | |
| 1024-55-409 | In distribution | |
| 1024-53-209 | In distribution | |
| 1024-11-111 | In distribution | |
| 1024-55-311 | In distribution | |
| 1024-55-310 | In distribution | |
| 1024-53-208 | In distribution | |
| 1024-07-200 | In distribution | |
| 1024-53-111 | In distribution | |
| 1024-54-308 | In distribution | |
| 1024-56-608 | In distribution | |
| 1024-54-408 | In distribution | |
| 1024-11-109 | In distribution | |
| 1024-11-409 | In distribution | |
| 1024-54-411 | In distribution | |
| 1024-12-609 | In distribution | |
| 1024-53-407 | In distribution | |
| 1024-53-611 | In distribution | |
| 1024-08-600 | In distribution | |
| 1024-55-108 | In distribution | |
| 1024-54-510 | In distribution | |
| 1024-54-211 | In distribution | |
| 1024-53-108 | In distribution | |
| 1024-52-400 | In distribution | |
| 1024-53-307 | In distribution | |
| 1024-12-211 | In distribution | |
| 1024-55-507 | In distribution | |
| 1024-52-300 | In distribution | |
| 1024-56-511 | In distribution | |
| 1024-12-509 | In distribution | |
| 1024-56-407 | In distribution | |
| 1024-54-410 | In distribution | |
| 1024-54-108 | In distribution | |
| 1024-55-307 | In distribution | |
| 1024-03-400 | In distribution | |
| 1024-55-407 | In distribution | |
| 1024-11-309 | In distribution | |
| 1024-55-308 | In distribution | |
| 1024-56-209 | In distribution | |
| 1024-12-111 | In distribution | |
| 1024-08-400 | In distribution | |
| 1024-56-308 | In distribution | |
| 1024-54-611 | In distribution | |
| 1024-55-609 | In distribution | |
| 1024-53-310 | In distribution | |
| 1024-56-207 | In distribution | |
| 1024-54-610 | In distribution | |
| 1024-54-110 | In distribution | |
| 1024-56-108 | In distribution | |
| 1024-54-608 | In distribution | |
| 1024-55-208 | In distribution | |
| 1024-54-107 | In distribution | |
| 1024-52-200 | In distribution | |
| 1024-53-410 | In distribution | |
| 1024-04-500 | In distribution | |
| 1024-11-608 | In distribution | |
| 1024-55-411 | In distribution | |
| 1024-56-309 | In distribution | |
| 1024-53-211 | In distribution | |
| 1024-55-109 | In distribution | |
| 1024-55-309 | In distribution | |
| 1024-55-111 | In distribution | |
| 1024-55-110 | In distribution | |
| 1024-07-600 | In distribution | |
| 1024-54-511 | In distribution | |
| 1024-11-110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, 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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.