Initia Knee System— 510(k) K243295
Substantially EquivalentKyocera Medical Technologies, Inc.
FDA 510(k) clearance K243295 for Initia Knee System, Substantially Equivalent on 2025-01-13. Applicant: Kyocera Medical Technologies, Inc..
Clearance details
- Applicant
- Kyocera Medical Technologies, Inc.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redlands, CA, US
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.