Sigma
SIGMA TIBIAL INSERT FIXED BEARING CURVED PLUS 2.5 12.5mm XLK
21manufacturers in China registered for this device type
82catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K040166 |
| Record published | 2015-09-24 |
| Record revised | 2024-12-09 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-12-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 97-0453 | In distribution | |
| 96-0016 | In distribution | |
| 96-0083 | In distribution | |
| 97-0440 | In distribution | |
| 96-0087 | In distribution | |
| 97-0445 | In distribution | |
| 97-0471 | In distribution | |
| 97-0482 | In distribution | |
| 97-0451 | In distribution | |
| 97-0461 | In distribution | |
| 97-0442 | In distribution | |
| 97-0462 | In distribution | |
| 97-0422 | In distribution | |
| 97-0421 | In distribution | |
| 97-0481 | In distribution | |
| 96-0008 | In distribution | |
| 86-6499 | In distribution | |
| 97-0455 | In distribution | |
| 97-0472 | In distribution | |
| 96-0003 | In distribution | |
| 96-0082 | In distribution | |
| 1960-00-400 | In distribution | |
| 97-0464 | In distribution | |
| 1960-01-400 | In distribution | |
| 96-0081 | In distribution | |
| 97-0460 | In distribution | |
| 96-0014 | In distribution | |
| 97-0430 | In distribution | |
| 86-6468 | In distribution | |
| 96-0084 | In distribution | |
| 96-0085 | In distribution | |
| 97-0434 | In distribution | |
| 96-0006 | In distribution | |
| 97-0485 | In distribution | |
| 97-0480 | In distribution | |
| 97-0463 | In distribution | |
| 97-0450 | In distribution | |
| 97-0424 | In distribution | |
| 96-0090 | In distribution | |
| 97-0444 | In distribution | |
| 96-0088 | In distribution | |
| 97-0473 | In distribution | |
| 97-0433 | In distribution | |
| 96-0015 | In distribution | |
| 86-6498 | In distribution | |
| 97-0474 | In distribution | |
| 86-6469 | In distribution | |
| 96-0089 | In distribution | |
| 97-0441 | In distribution | |
| 96-0086 | In distribution | |
| 96-0018 | In distribution | |
| 96-0005 | In distribution | |
| 97-0423 | In distribution | |
| 97-0454 | In distribution | |
| 97-0420 | In distribution | |
| 97-0435 | In distribution | |
| 96-0012 | In distribution | |
| 97-0465 | In distribution | |
| 96-0007 | In distribution | |
| 97-0484 | In distribution | |
| 97-0452 | In distribution | |
| 97-0443 | In distribution | |
| 96-0002 | In distribution | |
| 97-0470 | In distribution | |
| 96-0004 | In distribution | |
| 96-0013 | In distribution | |
| 96-0091 | In distribution | |
| 97-0483 | In distribution | |
| 96-0017 | In distribution | |
| 97-0431 | In distribution | |
| 97-0475 | In distribution | |
| 96-0092 | In distribution | |
| 97-0432 | In distribution | |
| 94-0012 | Withdrawn | |
| 94-0019 | Withdrawn | |
| 94-0027 | Withdrawn | |
| 94-0018 | Withdrawn | |
| 94-0017 | Withdrawn | |
| 94-0022 | Withdrawn | |
| 94-0028 | Withdrawn | |
| 94-0014 | Withdrawn | |
| 94-0016 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170806 | 2017-06-15 |
| K160700 | 2016-06-10 |
Recalls Naming This Product
11 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 |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2018-07-18 | Class II | Employee error | This unit may be missing the screw/collet Assembly | 1 | 2019-04-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2013-12-09 | Class II | Process design | Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants | 2 | 2014-06-10 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2009-05-07 | Not classified | Process control | There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant. | 260 | 2010-10-25 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2006-09-14 | Not classified | Other | Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella. | 9 | 2007-04-26 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 2005-12-02 | |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 10 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 20 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-05-26 | Not classified | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. | 19 | 2005-12-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2003-12-22 | Not classified | Other | The collar was incorrectly etched for the R (right) and L (Left) orientation | 1 unit | 2004-09-23 |
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.