KLS Martin Cranial Implants - MR Conditional +6 more— 510(k) K252573

Clearance details

Device name as filed

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

Applicant

KLS-Martin L.P.

Product code

Code GXN

Device class

Class 2

Regulation

21 CFR 882.5330

Advisory panel

Neurology

Date received

2025-08-14

Decision date

2025-11-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jacksonville, FL, US

• K260709 — ClearFit Ti Ring 14mm (171750) +4 more2026-06-25
• K253116 — 3D MAC Titanium Cranial Plate (TCP) System2026-06-18
• K252251 — EASYMADE-TI2026-04-09
• K252958 — METICULY Patient-specific titanium mesh implant2026-01-14
• K243715 — Synthes Patient Specific Implants2025-11-12

• K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more2026-08-17
• K253660 — KLS Martin Pure Pectus System2026-02-20
• K254162 — KLS Martin Ixos System2026-02-20
• K250988 — KLS Martin Pure Pectus System2025-12-11
• K250865 — KLS Martin IPS Forearm System2025-11-14

Injury

208

Total

208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →