RESTORIS Multicompartmental Knee System
FDA 510(k) K150307 · Mako Surgical Corp.
510(k) numberK150307
Submission
- Device name
- RESTORIS Multicompartmental Knee System
- Applicant
- Mako Surgical Corp.
Fort Lauderdale, FL, US - Received
- February 9, 2015
- Decision date
- March 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Other 510(k)s with product code NPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133039 | Restoris Multicompartmental Knee SystemNPJ · Special | Mako Surgical Corporation | 12/10/2013SE |
| K093513 | Iduo Bicompartmental Knee Repair SystemNPJ · Special | Conformis, Inc. | 12/16/2009SE |
| K093056 | Smith & Nephew, Inc. Journey Select Knee SystemNPJ · Traditional | Smith & Nephew, Inc. | 12/15/2009SE |
| K090763 | Restoris Multicompartmental Knee (MCK) SystemNPJ · Traditional | Mako Surgical Corporation | 06/17/2009SE |
| K070849 | Depuy GCK Femoral and Tibial ComponentsNPJ · Traditional | DePuy Orthopaedics, Inc. | 06/26/2007SE |
| K061648 | Depuy Graduated Compartmental Knee (GCK)NPJ · Traditional | DePuy Orthopaedics, Inc. | 09/11/2006SE |
| K061569 | Smith & Nephew Competitor Deuce Femoral ComponentsNPJ · Special | Smith & Nephew, Inc. | 07/06/2006SE |
| K053488 | Conformis Bicompartmental Knee Repair SystemNPJ · Traditional | Conformis, Inc. | 03/09/2006SE |
| K052917 | Stryker Compartmental Knee SystemNPJ · Traditional | Howmedica Osteonics Corp. | 12/27/2005SE |
| K052265 | Smith & Nephew Competitor Duo Knee FemoralNPJ · Abbreviated | Smith & Nephew, Inc. | 12/27/2005SE |
More from Smith & Nephew, 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 Multicompartmental Knee System cleared by the FDA?
RESTORIS Multicompartmental Knee System (K150307) received a 510(k) decision of Substantially Equivalent on March 10, 2015, 29 days after the submission was received.
What is the product code of K150307?
The FDA product code is NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.