FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURACON TOTAL KNEE SYSTEM
K Number: K032163
·
Decision Sep 12, 2003
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
142
Applicant Total
288
Review Days
59
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Basic Information
- Device Name
- DURACON TOTAL KNEE SYSTEM
- K Number
- K032163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3565
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Osteonics Corp.
- Date Received
- July 15, 2003
- Decision Date
- September 12, 2003
- 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 |
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|---|---|---|---|
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| K130895 | REUNION RSA SHOULDER SYSTEM | Dec 27, 2013 | Substantially Equivalent |
| K123604 | ABG III MONOLITHIC HIP STEM | Aug 16, 2013 | Substantially Equivalent |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | Feb 22, 2013 | Substantially Equivalent |
| K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P | Feb 14, 2013 | Substantially Equivalent |
| K122853 | NOVEL FIT AND FILL STEM | Feb 1, 2013 | Substantially Equivalent |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Nov 1, 2012 | Substantially Equivalent |
| K121308 | HIP SYSTEMS | Jul 30, 2012 | Substantially Equivalent |
| K113409 | S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL | Feb 15, 2012 | Substantially Equivalent |