FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
K Number: K162256
·
Decision Oct 27, 2016
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
133
Applicant Total
11
Review Days
77
Basic Information
- Device Name
- Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
- K Number
- K162256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3565
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TOTAL JOINT ORTHOPEDICS, INC.
- Date Received
- August 11, 2016
- Decision Date
- October 27, 2016
- Product Code
- MBH
- 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 |
|---|---|---|---|
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBH), ordered by most recent decision date.
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Freedom® Total Knee System - Porous Tibial Base Plate
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Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
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Other Clearances by TOTAL JOINT ORTHOPEDICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K153310 | Klassic Knee System | Dec 17, 2015 | Substantially Equivalent |
| K153075 | Klassic Knee System | Nov 13, 2015 | Substantially Equivalent |
| K151440 | Klassic HD Hip System | Sep 3, 2015 | Substantially Equivalent |
| K150105 | Klassic Knee System-Sombrero Patella | Feb 17, 2015 | Substantially Equivalent |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | Oct 9, 2014 | Substantially Equivalent |
| K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION | May 16, 2014 | Substantially Equivalent |
| K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS | Mar 13, 2014 | Substantially Equivalent |
| K131454 | KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD | Feb 12, 2014 | Substantially Equivalent |
| K112906 | KLASSIC KNEE SYSTEM | Feb 1, 2012 | Substantially Equivalent |
| K100445 | KLASSIC HD HIP SYSTEM | Dec 3, 2010 | Substantially Equivalent |