Natural-Knee®
8 catalogue numbers from 6118-06-013, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer. 1 manufacturer in China is registered for this product code.
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | NJD |
| Device type | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3535 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K033810 |
| Record published | 2015-09-17 |
| Record revised | 2020-06-17 (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 |
|---|---|---|
| 6118-06-013 | Size 6, 13 mm | In distribution |
| 6118-06-011 | Size 6, 11 mm | In distribution |
| 6118-05-011 | Size 5, 11 mm | In distribution |
| 6118-05-009 | Size 5, 9 mm | In distribution |
| 6118-03-013 | Size 3, 13 mm | In distribution |
| 6118-03-011 | Size 3, 11 mm | In distribution |
| 6118-03-009 | Size 3, 9 mm | In distribution |
| 6118-02-011 | Size 2, 11 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Engage Partial Knee System | Engage Uni, LLC | 385 |
| Engage | Smith & Nephew, Inc. | 112 |
| Restoris PST | Mako Surgical Corp. | 10 |
| Mako | Mako Surgical Corp. | 6 |
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 |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2014-02-25 | Class II | Storage | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being | 3638 units | 2015-03-24 |
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.