Restoris
MCK ONLAY INSERT TRIAL (SIZE 8 X 10mm)
10manufacturers in China registered for this device type
118catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Mako Surgical Corp., United States |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K082172 |
| Record published | 2016-09-24 |
| Record revised | 2022-03-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 160220-3 | Size: LGE | In distribution |
| 170714-1 | Size: 4 | In distribution |
| 180722-1 | Thickness: 6.5 Millimeter | In distribution |
| 180503 | Side: Left Medial/Right Lateral | In distribution |
| 180511 | Side: Right Medial/Left Lateral | In distribution |
| 170512 | Side: Right Medial/Left Lateral | In distribution |
| 180726-2 | Size: 6 | In distribution |
| 180615 | Side: Right Medial/Left Lateral | In distribution |
| 180724-3 | Size: 4 | In distribution |
| 160148 | Size: 8 | In distribution |
| 170708-3 | Thickness: 10.0 Millimeter | In distribution |
| 170406 | Size: 6 | In distribution |
| 180708-8 | Size: 8 | In distribution |
| 170716-1 | Size: 6 | In distribution |
| 170506 | Side: Left Medial/Right Lateral | In distribution |
| 160205 | In distribution | |
| 170701-9 | Size: 1 | In distribution |
| 180708-7 | Size: 8 | In distribution |
| 170402 | Size: 2 | In distribution |
| 160137 | Size: 7 | In distribution |
| 180706-9 | Size: 6 | In distribution |
| 160153 | Size: 3 | In distribution |
| 170418 | Size: 8 | In distribution |
| 170707-2 | Size: 7 | In distribution |
| 170703-2 | Thickness: 9.0 Millimeter | In distribution |
| 180721-3 | Size: 1 | In distribution |
| 170615 | Size: 5 | In distribution |
| 180728-3 | Thickness: 8.5 Millimeter | In distribution |
| 170714-3 | Size: 4 | In distribution |
| 180603 | Side: Left Medial/Right Lateral | In distribution |
| 180402 | Side: LEFT | In distribution |
| 180515 | Side: Right Medial/Left Lateral | In distribution |
| 160145 | Side: Left Medial/Right Lateral | In distribution |
| 180508 | Side: Left Medial/Right Lateral | In distribution |
| 180704-3 | Size: 4 | In distribution |
| 180727-7 | Size: 7 | In distribution |
| 180404 | Size: 4 | In distribution |
| 170416 | Size: 6 | In distribution |
| 160113 | Side: RIGHT | In distribution |
| 120208 | In distribution | |
| 170702-8 | Thickness: 15.0 Millimeter | In distribution |
| 170502 | Side: Left Medial/Right Lateral | In distribution |
| 160115 | Size: 5 | In distribution |
| 180702-4 | Size: 2 | In distribution |
| 170705-5 | Size: 5 | In distribution |
| 180703-3 | Thickness: 10.0 Millimeter | In distribution |
| 170617 | Side: Right Medial/Left Lateral | In distribution |
| 170706-5 | Thickness: 12.0 Millimeter | In distribution |
| 180706-5 | Size: 6 | In distribution |
| 160124 | Side: Left Medial/Right Lateral | In distribution |
| 170413 | Side: RIGHT | In distribution |
| 180725-2 | Size: 5 | In distribution |
| 180708-4 | Size: 8 | In distribution |
| 180707-2 | Size: 7 | In distribution |
| 170511 | Side: Right Medial/Left Lateral | In distribution |
| 170706-3 | Size: 6 | In distribution |
| 170707-1 | Thickness: 8.0 Millimeter | In distribution |
| 160402 | In distribution | |
| 111550 | In distribution | |
| 180727-4 | Size: 7 | In distribution |
| 160111 | Size: 1 | In distribution |
| 170605 | Side: Left Medial/Right Lateral | In distribution |
| 180703-1 | Thickness: 8.0 Millimeter | In distribution |
| 180517 | Size: 7 | In distribution |
| 170404 | Size: 4 | In distribution |
| 180721-6 | Thickness: 11.5 Millimeter | In distribution |
| 170704-1 | Size: 4 | In distribution |
| 170702-6 | Size: 2 | In distribution |
| 160105 | Size: 5 | In distribution |
| 170708-6 | Size: 8 | In distribution |
| 180320-2 | Diameter: 29.0 Millimeter | In distribution |
| 180704-4 | Thickness: 11.0 Millimeter | In distribution |
| 180705-8 | Thickness: 15.0 Millimeter | In distribution |
| 180702-7 | Size: 2 | In distribution |
| 180611 | Side: Right Medial/Left Lateral | In distribution |
| 170320-2 | Diameter: 29.0 Millimeter | In distribution |
| 170707-8 | Thickness: 15.0 Millimeter | In distribution |
| 170711-2 | Size: 1 | In distribution |
| 170707-5 | Size: 7 | In distribution |
| 180707-3 | Size: 7 | In distribution |
| 180705-9 | Size: 5 | In distribution |
| 160202 | In distribution | |
| 180320-3 | Diameter: 32.0 Millimeter | In distribution |
| 180701-4 | Thickness: 11.0 Millimeter | In distribution |
| 180504 | Side: Left Medial/Right Lateral | In distribution |
| 160141 | Side: Left Medial/Right Lateral | In distribution |
| 180702-2 | Size: 2 | In distribution |
| 170611 | Size: 1 | In distribution |
| 170403 | Side: LEFT | In distribution |
| 170415 | Size: 5 | In distribution |
| 160143 | Size: 3 | In distribution |
| 180701-3 | Size: 1 | In distribution |
| 170501 | Size: 1 | In distribution |
| 180703-9 | Size: 3 | In distribution |
| 170320-5 | Diameter: 38.0 Millimeter | In distribution |
| 160142 | Side: Left Medial/Right Lateral | In distribution |
| 180417 | Side: RIGHT | In distribution |
| 170702-4 | Size: 2 | In distribution |
| 180705-7 | Size: 5 | In distribution |
| 180706-1 | Size: 6 | In distribution |
| 180701-2 | Thickness: 9.0 Millimeter | In distribution |
| 180723-9 | Thickness: 14.5 Millimeter | In distribution |
| 170713-2 | Thickness: 7.5 Millimeter | In distribution |
| 160403 | In distribution | |
| 170716-3 | Size: 6 | In distribution |
| 170320-6 | Diameter: 41.0 Millimeter | In distribution |
| 160146 | Side: Left Medial/Right Lateral | In distribution |
| 180724-2 | Size: 4 | In distribution |
| 170702-7 | Thickness: 14.0 Millimeter | In distribution |
| 180724-8 | Thickness: 13.5 Millimeter | In distribution |
| 180725-8 | Size: 5 | In distribution |
| 170414 | Side: RIGHT | In distribution |
| 170701-4 | Size: 1 | In distribution |
| 170603 | Size: 3 | In distribution |
| 170702-2 | Thickness: 9.0 Millimeter | In distribution |
| 180727-2 | Thickness: 7.5 Millimeter | In distribution |
| 180706-6 | Thickness: 13.0 Millimeter | In distribution |
| 180703-4 | Thickness: 11.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150410 | 2015-03-20 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2023-03-10 | Class II | Process change control | Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking | 52 units | |
| Howmedica Osteonics Corp | 510(k) number | 2023-03-10 | Class II | Process change control | Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking | 102 units | |
| Mako Surgical Corp. | 510(k) number | 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 |
| Mako Surgical Corp. | 510(k) number | 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 |
| Mako Surgical Corp. | 510(k) number | 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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.