Cleared Traditional

K254162 - KLS Martin Ixos System

K254162 is the FDA 510(k) clearance for KLS Martin Ixos System by KLS-Martin L.P.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K254162 · KLS-Martin L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
60d
Days
Class 2
Risk

K254162 is an FDA 510(k) clearance for the KLS Martin Ixos System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 20, 2026 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all KLS-Martin L.P. devices

Submission Details

510(k) Number K254162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2025
Decision Date February 20, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K254162.
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK™ Fixation System
K252166 · Globus Medical, Inc. · Feb 2026
KLS Martin Pure Pectus System
K253660 · KLS-Martin L.P. · Feb 2026
Wrist Fracture System
K251732 · Met One Technologies, LLC · Feb 2026
Arthrex Variable Angle (VA) Proximal Tibia Plating System
K253713 · Arthrex, Inc. · Jan 2026
TriMed Volar Bearing Plates (VBEAL-13-7S)
K254002 · TriMed, Inc. · Jan 2026