Home / 510(k) Clearances / K251472

510(k) K251472

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System by Inion OY — Product Code HBW

K251472 is an FDA 510(k) premarket notification submitted by Inion OY for the device "Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System". The FDA issued a decision of Substantially Equivalent on July 11, 2025. The device falls under product code HBW (Fastener, Plate, Cranioplasty), a Class II device regulated under 21 CFR 882.5360. Inion OY has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2025
Date Received
May 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Plate, Cranioplasty
Device Class
Class II
Regulation Number
882.5360
Review Panel
NE
Submission Type

Other clearances by Inion OY

  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K203105 — Inion CompressOn Screw (January 13, 2021)
  • K191764 — Inion BioRestore (July 31, 2019)
  • K151360 — Inion Spinal Graft Containment System (October 6, 2015)
  • K133932 — INION FREEDOMPIN (April 11, 2014)
  • K123672 — INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) (February 27, 2013)
  • K122890 — INION CPS ORBITAL PLATES (January 29, 2013)
  • K090177 — INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (February 20, 2009)
  • K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM (July 11, 2008)
  • K070998 — INION BIORESTORE (October 11, 2007)

Other clearances for product code HBW

  • K231208 — Stryker Resorbable Fixation System (August 14, 2023)
  • K171152 — Stryker Universal Neuro III System AXS Screw (May 19, 2017)
  • K151387 — Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Bla (June 24, 2015)
  • K141385 — DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (March 27, 2015)
  • K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (December 3, 2010)
  • K001353 — MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPL (March 13, 2001)

FDA data resources