Restoris Esyntial
14 catalogue numbers from 180744-1, listed by Mako Surgical Corp., United States, under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
14catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Mako Surgical Corp., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K133039 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| 180744-1 | Thickness: 8.0 Millimeter | In distribution |
| 180745-7 | Thickness: 14.0 Millimeter | In distribution |
| 180741-2 | Size: 1 | In distribution |
| 180743-1 | Size: 3 | In distribution |
| 180746-3 | Size: 6 | In distribution |
| 180742-9 | Thickness: 16.0 Millimeter | In distribution |
| 180745-4 | Size: 5 | In distribution |
| 180742-4 | Size: 2 | In distribution |
| 180741-1 | Thickness: 8.0 Millimeter | In distribution |
| 180743-5 | Thickness: 12.0 Millimeter | In distribution |
| 180746-1 | Thickness: 8.0 Millimeter | In distribution |
| 180748-1 | Size: 8 | In distribution |
| 180745-6 | Thickness: 13.0 Millimeter | In distribution |
| 180741-5 | Thickness: 12.0 Millimeter | 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 |
| Sigma | Depuy (Ireland) | 16 |
Showing 12 of 47. All products under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082088 | 2008-10-22 |
| K080029 | 2008-05-16 |
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.