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510(k) Data Aggregation
K Number
K250037Device Name
Incompass Total Ankle System
Manufacturer
Wright Medical Technology, Inc. (Stryker)
Date Cleared
2025-06-20
(163 days)
Product Code
HSN
Regulation Number
888.3110Why did this record match?
Applicant Name (Manufacturer) :
Wright Medical Technology, Inc. (Stryker)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
Device Description
Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.
Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.
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