FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KLS Martin Ixos System
K Number: K254162
·
Decision Feb 20, 2026
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
20
Review Days
60
Basic Information
- Device Name
- KLS Martin Ixos System
- K Number
- K254162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KLS Martin L.P.
- Date Received
- December 22, 2025
- Decision Date
- February 20, 2026
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by KLS Martin L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K250620 | KLS Martin Ixos System | Aug 15, 2025 | Substantially Equivalent |
| K221938 | KLS Martin Pure Pectus System | Mar 28, 2023 | Substantially Equivalent |
| K220050 | KLS Martin IPS Distraction | Aug 11, 2022 | Substantially Equivalent |
| K173320 | KLS Martin L1 MMF System | Feb 23, 2018 | Substantially Equivalent |
| K163579 | KLS Martin Individual Patient Solutions | Nov 21, 2017 | Substantially Equivalent |
| K163315 | Internal Distraction - Sterile | May 5, 2017 | Substantially Equivalent |
| K170124 | Level One Hand Plating System | Mar 9, 2017 | Substantially Equivalent |
| K161259 | KLS Martin Cannulated Headless Screws | Dec 19, 2016 | Substantially Equivalent |
| K161470 | Internal Distraction - Sterile | Dec 1, 2016 | Substantially Equivalent |
| K151983 | KLS Martin LSS Plating System | Apr 6, 2016 | Substantially Equivalent |