Restoris
MCK ONLAY INSERT TRIAL (SIZE 8 X 12mm)
7manufacturers in China registered for this device type
76catalogue 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) | 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 |
| Sizes | Height 10 to 16 mm; length 1.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 170708-5 | Size: 8 | In distribution |
| 180724-9 | Size: 4 | In distribution |
| 180725-9 | Size: 5 | In distribution |
| 180723-2 | Thickness: 7.5 Millimeter | In distribution |
| 180723-1 | Thickness: 6.5 Millimeter | In distribution |
| 160122 | Size: 2 | In distribution |
| 170706-2 | Thickness: 9.0 Millimeter | In distribution |
| 180707-4 | Size: 7 | In distribution |
| 160101 | Size: 1 | In distribution |
| 170601 | Side: Left Medial/Right Lateral | In distribution |
| 180707-7 | Size: 7 | In distribution |
| 170608 | Side: Left Medial/Right Lateral | In distribution |
| 180705-6 | Thickness: 13.0 Millimeter | In distribution |
| 180516 | Size: 6 | In distribution |
| 170618 | Size: 8 | In distribution |
| 160118 | Side: RIGHT | In distribution |
| 160102 | Size: 2 | In distribution |
| 180726-1 | Thickness: 6.5 Millimeter | In distribution |
| 160171 | In distribution | |
| 180725-6 | Size: 5 | In distribution |
| 180501 | Side: Left Medial/Right Lateral | In distribution |
| 120209-4 | Length 1.75 in | In distribution |
| 180701-6 | Thickness: 13.0 Millimeter | In distribution |
| 111541-3 | Diameter: 41.0 Millimeter | In distribution |
| 180613 | Side: Right Medial/Left Lateral | In distribution |
| 180703-8 | Thickness: 15.0 Millimeter | In distribution |
| 180405 | Size: 5 | In distribution |
| 170607 | Side: Left Medial/Right Lateral | In distribution |
| 180706-2 | Size: 6 | In distribution |
| 180726-8 | Size: 6 | In distribution |
| 180704-9 | Size: 4 | In distribution |
| 180514 | Size: 4 | In distribution |
| 180725-1 | Thickness: 6.5 Millimeter | In distribution |
| 180725-3 | Thickness: 8.5 Millimeter | In distribution |
| 170705-2 | Thickness: 9.0 Millimeter | In distribution |
| 180703-2 | Size: 3 | In distribution |
| 180502 | Side: Left Medial/Right Lateral | In distribution |
| 180708-5 | Size: 8 | In distribution |
| 180727-5 | Size: 7 | In distribution |
| 180728-4 | Size: 8 | In distribution |
| 170708-8 | Thickness: 15.0 Millimeter | In distribution |
| 180727-6 | Size: 7 | In distribution |
| 170702-1 | Thickness: 8.0 Millimeter | In distribution |
| 180722-5 | Size: 2 | In distribution |
| 180616 | Side: Right Medial/Left Lateral | In distribution |
| 170717-3 | Thickness: 8.5 Millimeter | In distribution |
| 180706-3 | Size: 6 | In distribution |
| 180725-7 | Size: 5 | In distribution |
| 180705-5 | Size: 5 | In distribution |
| 120063 | In distribution | |
| 170708-4 | Size: 8 | In distribution |
| 180601 | Side: Left Medial/Right Lateral | In distribution |
| 170708-2 | Size: 8 | In distribution |
| 170612 | Size: 2 | In distribution |
| 160107 | Side: LEFT | In distribution |
| 180513 | Side: Right Medial/Left Lateral | In distribution |
| 180703-5 | Thickness: 12.0 Millimeter | In distribution |
| 180416 | Side: RIGHT | In distribution |
| 170503 | Size: 3 | In distribution |
| 180704-8 | Size: 4 | In distribution |
| 180605 | Side: Left Medial/Right Lateral | In distribution |
| 160114 | Side: RIGHT | In distribution |
| 160152 | Size: 2 | In distribution |
| 170712-2 | Size: 2 | In distribution |
| 180401 | Size: 1 | In distribution |
| 180702-5 | Thickness: 12.0 Millimeter | In distribution |
| 180702-3 | Height 10.0 mm | In distribution |
| 170515 | Side: Right Medial/Left Lateral | In distribution |
| 180704-2 | Thickness: 9.0 Millimeter | In distribution |
| 160157 | Size: 7 | In distribution |
| 170701-3 | Thickness: 10.0 Millimeter | In distribution |
| 160405 | In distribution | |
| 180722-2 | Thickness: 7.5 Millimeter | In distribution |
| 170708-1 | Size: 8 | In distribution |
| 170712-1 | Thickness: 6.5 Millimeter | In distribution |
| 180726-6 | Size: 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 103 |
| 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 |
| Restoris Esyntial | Mako Surgical Corp. | 14 |
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 |
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 |
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.