Home / 510(k) Clearances / K252573

510(k) K252573

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 by KLS-Martin L.P. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2025
Date Received
August 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

Other clearances by KLS-Martin L.P.

  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K250988 — KLS Martin Pure Pectus System (December 11, 2025)
  • K250865 — KLS Martin IPS Forearm System (November 14, 2025)
  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K241018 — KLS Martin Orthopedic Implants - MR Conditional (July 12, 2024)
  • K230211 — CranioXpand (November 21, 2023)
  • K222624 — KLS Martin LINOS Wrist System (May 25, 2023)
  • K222397 — KLS Martin Level One Rib Fixation System (March 29, 2023)
  • K210731 — KLS Martin Individual Patient Solutions (July 18, 2022)

Other clearances for product code GXN

  • K252958 — METICULY Patient-specific titanium mesh implant (January 14, 2026)
  • K243715 — Synthes Patient Specific Implants (November 12, 2025)
  • K240567 — CustomizedBone Service (March 28, 2024)
  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (October 28, 2022)
  • K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant (August 26, 2022)
  • K210099 — Meticuly Patient-Specific Titanium Mesh Implant (December 21, 2021)
  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)
  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)
  • K203349 — Longeviti ClearFit Cranial Implant (December 16, 2020)