Restoris Porous Partial Knee System
FDA 510(k) K150410 · Mako Surgical Corporation
510(k) numberK150410
Submission
- Device name
- Restoris Porous Partial Knee System
- Applicant
- Mako Surgical Corporation
Fort Lauderdale, FL, US - Received
- February 18, 2015
- Decision date
- March 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3530
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193549 | SIGMA High Performance (HP) Partial Knee SystemHRY · Traditional | Depuy Ireland UC | 04/16/2020SE |
| K190633 | NanoOrtho NanoKnee® SystemHRY · Traditional | Nanoortho, LLC | 12/20/2019SE |
| K152631 | MPO Total Knee Systems MR LabelingHRY · Traditional | Microport Orthopedics, Inc. | 03/23/2016SE |
| K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)HRY · Traditional | Biomet UK, Ltd. | 03/28/2014SE |
| K131167 | UnivationHRY · Traditional | Aesculap Implant Systems, LLC | 10/17/2013SE |
| K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford…HRY · Traditional | Biomet Manufacturing Corp | 10/22/2012SE |
| K110415 | Signature Planner / Signature GuidesHRY · Traditional | Materialise NV | 05/16/2011SE |
| K100973 | Evolution Unicondylar Knee SystemHRY · Traditional | Wrightmedicaltechnologyinc | 08/10/2010SE |
| K082567 | Stryker Compartmental Knee System Line ExtensionHRY · Special | Howmedica Osteonics Corp. | 10/03/2008SE |
| K081293 | Univation Unicondylar Knee SystemHRY · Traditional | Aesculap Implant Systems, Inc. | 09/22/2008SE |
More from Aesculap Implant Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260222 | Mako Total Knee ApplicationOLO · Special | 02/25/2026SE |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip PointerOLO · Traditional | 04/25/2025SE |
| K243751 | Mako Total Hip Application 5.0OLO · Traditional | 03/05/2025SE |
| K242373 | Mako Shoulder Application (1.0)OLO · Traditional | 11/07/2024SE |
| K241011 | Mako Total Knee ApplicationOLO · Traditional | 06/11/2024SE |
| K220930 | Restoris Multi-Compartmental Knee SystemHSX · Traditional | 06/02/2022SE |
| K220459 | Mako Total Knee ApplicationOLO · Traditional | 04/15/2022SE |
| K193515 | Mako Total Knee ApplicationOLO · Traditional | 07/14/2020SE |
| K193128 | Mako Total Hip ApplicationOLO · Traditional | 02/02/2020SE |
| K191998 | Mako Total Hip Application, Mako Total Knee ApplicationOLO · Traditional | 09/24/2019SE |
Questions and answers
When was Restoris Porous Partial Knee System cleared by the FDA?
Restoris Porous Partial Knee System (K150410) received a 510(k) decision of Substantially Equivalent on March 20, 2015, 30 days after the submission was received.
What is the product code of K150410?
The FDA product code is HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3530.