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510(k) K253161

Balanced Knee System TriMax Porous Femoral Components by Ortho Development Corp. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
September 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

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  • K133449 — KASM KNEE ARTICULATING SPACER MOLDS (February 18, 2014)
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