FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
K Number: K082088
·
Decision Oct 22, 2008
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
26
Applicant Total
33
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
- K Number
- K082088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mako Surgical Corp.
- Date Received
- July 24, 2008
- Decision Date
- October 22, 2008
- Product Code
- KRR
- 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 |
|---|---|---|---|
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRR), ordered by most recent decision date.
Overture Orthopaedics Patellofemoral System
FDA 510(k)
FDA Class 2
·Orthopedic
Episealer Patellofemoral System
FDA 510(k)
FDA Class 2
·Orthopedic
Avon Patello-femoral Joint Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
MOTO PFJ System
FDA 510(k)
FDA Class 2
·Orthopedic
Patello-Femoral Wave (Kahuna) Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex iBalance BiCompartmental Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Mako Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K260222 | Mako Total Knee Application | Feb 25, 2026 | Substantially Equivalent |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Apr 25, 2025 | Substantially Equivalent |
| K243751 | Mako Total Hip Application 5.0 | Mar 5, 2025 | Substantially Equivalent |
| K242373 | Mako Shoulder Application (1.0) | Nov 7, 2024 | Substantially Equivalent |
| K241011 | Mako Total Knee Application | Jun 11, 2024 | Substantially Equivalent |
| K220930 | Restoris Multi-Compartmental Knee System | Jun 2, 2022 | Substantially Equivalent |
| K220459 | Mako Total Knee Application | Apr 15, 2022 | Substantially Equivalent |
| K193515 | Mako Total Knee Application | Jul 14, 2020 | Substantially Equivalent |
| K193128 | Mako Total Hip Application | Feb 2, 2020 | Substantially Equivalent |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | Sep 24, 2019 | Substantially Equivalent |