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510(k) Data Aggregation
K Number
K232114Device Name
TRIBRID® Unicompartmental Knee System
Manufacturer
Kyocera Medical Technologies Inc.
Date Cleared
2024-04-04
(265 days)
Product Code
HSX, JWH, OIY
Regulation Number
888.3520Why did this record match?
Applicant Name (Manufacturer) :
Kyocera Medical Technologies Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kyocera TRIBRID® Unicompartmental Knee System is indicated for use in patients with the following:
- Painful and disabled knee joint resulting from osteoarthritis, or idiopathic osteonecrosis, of . either the medial or lateral compartments.
- Correction of varus, valgus, or posttraumatic deformity. .
- As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. .
- Revision procedures where other treatments or devices have failed. ●
This device is intended for cemented use only.
Device Description
KMTI's TRIBRID® Unicompartmental Knee System is a partial knee replacement prostheses intended for application with bone cement. Partial knee replacement components include femoral and tibial components. Femoral baseplates are CoCrMo Alloy while the Tibial implants are Ti6Al4V Alloy. The Tibial bearing inserts are made from Ultra-High Molecular Weight Polyethylene (UHMWPE) variations. Components are available in a variety of designs and size ranges intended for both primary and revision applications.
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