K251453
- 510(k) number
- K251453
- Device name
- Arthrex iBalance Partial Knee System
- Applicant
- Arthrex, Inc. FL · US
- Product code
- HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cem
- Decision date
- 2025-07-01
- Date received
- 2025-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K251453.pdf
Official FDA record: K251453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.