Restoris Esyntial
13 catalogue numbers from 180747-1, listed by Mako Surgical Corp., United States, under Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 3 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1). 3 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 |
Record
| Listed by | Mako Surgical Corp., United States |
|---|---|
| FDA product code | NPJ |
| Device type | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 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 |
|---|---|---|
| 180747-1 | Thickness: 8.0 Millimeter | In distribution |
| 180743-6 | Size: 3 | In distribution |
| 180741-7 | Size: 1 | In distribution |
| 180744-3 | Size: 4 | In distribution |
| 180745-2 | Size: 5 | In distribution |
| 180744-6 | Size: 4 | In distribution |
| 180747-9 | Size: 7 | In distribution |
| 180746-4 | Size: 6 | In distribution |
| 180741-6 | Size: 1 | In distribution |
| 180744-4 | Thickness: 11.0 Millimeter | In distribution |
| 180745-1 | Size: 5 | In distribution |
| 180747-8 | Thickness: 15.0 Millimeter | In distribution |
| 180742-1 | Size: 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Restoris | Mako Surgical Corp. | 101 |
| Sigma | Depuy (Ireland) | 64 |
| Instrument | Howmedica Osteonics Corp | 62 |
| Triathlon | Howmedica Osteonics Corp | 33 |
| Journey | Smith & Nephew, Inc. | 24 |
| iDuo® iPoly™ Insert Kit | ConforMIS, Inc. | 15 |
| Mako | Mako Surgical Corp. | 7 |
| Specialty Triathlon TS Trial Assessment Guide Size 8 Right | Howmedica Osteonics Corp | 6 |
| iDuo® Patella Trial | ConforMIS, Inc. | 4 |
| Unix | Howmedica Osteonics Corp | 3 |
| iDuo® Patella Sizer | ConforMIS, Inc. | 3 |
| iDuo® Patella | ConforMIS, Inc. | 2 |
Showing 12 of 21. All products under Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150307 | 2015-03-10 |
| K133039 | 2013-12-10 |
| K090763 | 2009-06-17 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2018-01-19 | Class II | Under Investigation by firm | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. | 575 units total (400 US, 175 OUS) | 2020-09-16 |
| 2016-01-15 | Class II | Unknown/Undetermined by firm | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. | 146 | 2019-08-06 |
| 2014-01-09 | Class II | Error in labeling | The product may be mislabeled and could result in the incorrect implant being used. | 41 units | 2014-08-14 |
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.