KLS Martin Ixos System— 510(k) K254162
Substantially EquivalentKLS Martin L.P.
FDA 510(k) clearance K254162 for KLS Martin Ixos System, Substantially Equivalent on 2026-02-20. Applicant: KLS Martin L.P.. Device class: 2.
Summary
KLS Martin's KLS Martin Ixos System is filed under product code HRS, bone fixation plate. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
KLS Martin filed from Jacksonville, Florida. FDA found it substantially equivalent 60 calendar days after receipt (December 22, 2025 to February 20, 2026).
Clearance details
- Applicant
- KLS Martin L.P.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code HRS
view allMore clearances from KLS Martin L.P.
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.