AS Columbus® Revision
AS Columbus TIB.HEMI-SP.T3/3+ 15MM RM/LL
21manufacturers in China registered for this device type
72catalogue numbers in this listing
6510(k) clearances naming this product code
8recalls on this 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 | Aesculap AG, Germany |
|---|---|
| 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2025-11-13 (version 9) |
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 | 2025-01-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NR054Z | Implant Fixation : cemented | Withdrawn |
| NR567Z | Implant Fixation : cemented | Withdrawn |
| NR466Z | Height : 5.000 MM | Withdrawn |
| NR053Z | Height : 10.000 MM | Withdrawn |
| NR465Z | Implant Fixation : cemented | Withdrawn |
| NR062Z | Implant Fixation : cemented | Withdrawn |
| NR463Z | Height : 5.000 MM | Withdrawn |
| NR052Z | Height : 5.000 MM | Withdrawn |
| NR475Z | Implant Fixation : cemented | Withdrawn |
| NR566Z | Implant Fixation : cemented | Withdrawn |
| NR565Z | Height : 5.000 MM | Withdrawn |
| NR257Z | Implant Fixation : cemented | Withdrawn |
| NR561Z | Height : 5.000 MM | Withdrawn |
| NR040Z | Implant Fixation : cemented | Withdrawn |
| NR252Z | Height : 5.000 MM | Withdrawn |
| NR462Z | Implant Fixation : cemented | Withdrawn |
| NR248Z | Implant Fixation : cemented | Withdrawn |
| NR262Z | Implant Fixation : cemented | Withdrawn |
| NR250Z | Height : 15.000 MM | Withdrawn |
| NR564Z | Implant Fixation : cemented | Withdrawn |
| NR577Z | Implant Fixation : cemented | Withdrawn |
| NR048Z | Implant Fixation : cemented | Withdrawn |
| NR477Z | Implant Fixation : cemented | Withdrawn |
| NR245Z | Height : 10.000 MM | Withdrawn |
| NR254Z | Implant Fixation : cemented | Withdrawn |
| NR476Z | Height : 10.000 MM | Withdrawn |
| NR240Z | Implant Fixation : cemented | Withdrawn |
| NR061Z | Implant Fixation : cemented | Withdrawn |
| NR246Z | Height : 15.000 MM | Withdrawn |
| NR587Z | Height : 15.000 MM | Withdrawn |
| NR046Z | Implant Fixation : cemented | Withdrawn |
| NR474Z | Implant Fixation : cemented | Withdrawn |
| NR574Z | Implant Fixation : cemented | Withdrawn |
| NR060Z | Height : 5.000 MM | Withdrawn |
| NR256Z | Implant Fixation : cemented | Withdrawn |
| NR572Z | Implant Fixation : cemented | Withdrawn |
| NR571Z | Height : 10.000 MM | Withdrawn |
| NR241Z | Height : 10.000 MM | Withdrawn |
| NR484Z | Height : 15.000 MM | Withdrawn |
| NR050Z | Height : 15.000 MM | Withdrawn |
| NR258Z | Implant Fixation : cemented | Withdrawn |
| NR058Z | Implant Fixation : cemented | Withdrawn |
| NR472Z | Implant Fixation : cemented | Withdrawn |
| NR041Z | Implant Fixation : cemented | Withdrawn |
| NR562Z | Implant Fixation : cemented | Withdrawn |
| NR461Z | Height : 5.000 MM | Withdrawn |
| NR467Z | Height : 5.000 MM | Withdrawn |
| NR486Z | Implant Fixation : cemented | Withdrawn |
| NR260Z | Height : 5.000 MM | Withdrawn |
| NR563Z | Implant Fixation : cemented | Withdrawn |
| NR261Z | Implant Fixation : cemented | Withdrawn |
| NR585Z | Height : 15.000 MM | Withdrawn |
| NR056Z | Implant Fixation : cemented | Withdrawn |
| NR584Z | Implant Fixation : cemented | Withdrawn |
| NR242Z | Height : 15.000 MM | Withdrawn |
| NR045Z | Height : 10.000 MM | Withdrawn |
| NR576Z | Height : 10.000 MM | Withdrawn |
| NR244Z | Height : 5.000 MM | Withdrawn |
| NR573Z | Implant Fixation : cemented | Withdrawn |
| NR049Z | Implant Fixation : cemented | Withdrawn |
| NR485Z | Height : 15.000 MM | Withdrawn |
| NR044Z | Height : 5.000 MM | Withdrawn |
| NR473Z | Implant Fixation : cemented | Withdrawn |
| NR042Z | Implant Fixation : cemented | Withdrawn |
| NR249Z | Implant Fixation : cemented | Withdrawn |
| NR253Z | Implant Fixation : cemented | Withdrawn |
| NR464Z | Implant Fixation : cemented | Withdrawn |
| NR057Z | Implant Fixation : cemented | Withdrawn |
| NR471Z | Implant Fixation : cemented | Withdrawn |
| NR487Z | Height : 15.000 MM | Withdrawn |
| NR586Z | Implant Fixation : cemented | Withdrawn |
| NR575Z | Implant Fixation : cemented | 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 |
|---|---|
| K053579 | 2006-05-17 |
| K053390 | 2006-02-06 |
| K030367 | 2003-08-21 |
| K023788 | 2002-12-13 |
| K022672 | 2002-11-08 |
| K021313 | 2002-07-22 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-01-21 | Class II | Material/Component Contamination | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. | 2021-09-22 | |
| 2020-01-21 | Class II | Material/Component Contamination | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. | 2021-09-22 | |
| 2020-01-21 | Class II | Material/Component Contamination | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. | 24010 | 2021-09-22 |
| 2020-01-21 | Class II | Material/Component Contamination | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. | 2021-09-22 | |
| 2020-01-21 | Class II | Material/Component Contamination | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. | 2021-09-22 | |
| 2015-11-30 | Class II | Packaging change control | Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US fo | 1232 | 2016-10-13 |
| 2013-09-19 | Class II | Component change control | The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. | 24 | 2014-12-22 |
| 2012-02-21 | Class II | Nonconforming Material/Component | During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem. | 8 | 2014-01-15 |
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.