FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VEGA KNEE SYSTEM
K Number: K121879
·
Decision Jul 27, 2012
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
7
Review Days
29
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
- VEGA KNEE SYSTEM
- K Number
- K121879
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap Implant Systems
- Date Received
- June 28, 2012
- Decision Date
- July 27, 2012
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Aesculap Implant Systems
| K Number | Device Name | ||
|---|---|---|---|
| K140452 | VEGA KNEE SYSTEM | Mar 25, 2014 | Substantially Equivalent |
| K101815 | ENDURO KNEE SYSTEM | Dec 20, 2010 | Substantially Equivalent |
| K100623 | AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM | Jun 9, 2010 | Substantially Equivalent |
| K090299 | BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS | Apr 24, 2009 | Substantially Equivalent |
| K090657 | MODIFICATION TO: S4 SPINAL SYSTEM | Apr 20, 2009 | Substantially Equivalent |
| K071945 | S4 SPINAL SYSTEM | Sep 20, 2007 | Substantially Equivalent |