FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESTORIS Multicompartmental Knee System
K Number: K150307
·
Decision Mar 10, 2015
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
11
Applicant Total
16
Review Days
29
Basic Information
- Device Name
- RESTORIS Multicompartmental Knee System
- K Number
- K150307
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAKO SURGICAL CORP.
- Date Received
- February 9, 2015
- Decision Date
- March 10, 2015
- Product Code
- NPJ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPJ), ordered by most recent decision date.
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
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·Orthopedic
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
FDA 510(k)
FDA Class 2
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RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by MAKO SURGICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K143752 | Total Knee Application (TKA) | Aug 6, 2015 | Substantially Equivalent |
| K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Jul 8, 2014 | Substantially Equivalent |
| K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA | Feb 24, 2010 | Substantially Equivalent |
| K091998 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | Sep 28, 2009 | Substantially Equivalent |
| K083644 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | Jun 19, 2009 | Substantially Equivalent |
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | Nov 25, 2008 | Substantially Equivalent |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | Oct 22, 2008 | Substantially Equivalent |
| K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III | Oct 15, 2008 | Substantially Equivalent |
| K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II | Jun 20, 2008 | Substantially Equivalent |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | May 16, 2008 | Substantially Equivalent |