# K251472: Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Jul 11, 2025 after 59 days
- Product code: HBW (Fastener, Plate, Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010351 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010352: CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, Inion, Ltd. (2001) Summary page 5.
- K033194: Inion CPS Baby 1.5 Bioabsorbable System, Inion, Ltd. (2003) Summary page 5.
- K051341: Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058 and PLT-1059, Inion, Ltd. (2005) Summary page 5.
- K052444: Inion CPS Baby 1.5 Bioabsorbable Fixation System, Inion, Ltd. (2005) Summary page 5.

## Indications for use
Inion CPS™ 1.5 Baby Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures in the craniofacial skeleton (e.g., infant craniofacial surgery, craniosynostosis, congenital malformations, craniotomy flap fixation), mid-face and maxilla. The Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures and to maintain the relative position of bone grafts or bone graft substitutes in the cranium, including craniotomy flap fixation.

Source page: https://510kreport.com/device/K251472
Methodology: https://510kreport.com/methodology