FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K Number: K023667
·
Decision Dec 24, 2002
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
85
Applicant Total
38
Review Days
54
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
- RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
- K Number
- K023667
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3510
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plus Orthopedics
- Date Received
- October 31, 2002
- Decision Date
- December 24, 2002
- Product Code
- KRO
- 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 |
|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRO), ordered by most recent decision date.
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
FDA 510(k)
FDA Class 2
·Orthopedic
Stem Extension Line (USTAR II System)
FDA 510(k)
FDA Class 2
·Orthopedic
Triathlon® Hinge Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Revision Hinge Knee
FDA 510(k)
FDA Class 2
·Orthopedic
EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Plus Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K032126 | PROMOS SHOULDER | Jan 8, 2004 | Substantially Equivalent |
| K033763 | MODIFICATION TO SLIM GLIDING NAIL SYSTEM | Dec 18, 2003 | Substantially Equivalent |
| K032709 | MODULAR PLUS HIP STEM | Sep 23, 2003 | Substantially Equivalent |
| K032548 | IP-XS COMPRESSION NAIL SYSTEM | Sep 10, 2003 | Substantially Equivalent |
| K032215 | VKS/TC-PLUS REVISION KNEE | Aug 8, 2003 | Substantially Equivalent |
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE | Jul 25, 2003 | Substantially Equivalent |
| K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM | Jun 6, 2003 | Substantially Equivalent |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | Apr 24, 2003 | Substantially Equivalent |
| K024134 | UNI HIP STEM | Jan 15, 2003 | Substantially Equivalent |
| K023416 | MODIFICATION TO VKS KNEE SYSTEM | Nov 8, 2002 | Substantially Equivalent |