# K251441: Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Nov 7, 2025 after 182 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K010352 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K122890: Inion CPS Orbital Plates, Inion OY (2013) Summary page 5.
- K013039: Inion CPS 2.0 Orthognathic Plate, Inion, Ltd. (2001) Summary page 5.
- K022981: Inion CPS 2.5/2.8 Screw, Inion, Ltd. (2002) Summary page 5.
- K020266: Inion CPS Bsso Screw, Inion, Ltd. (2002) Summary page 5.
- K010351: Inion CPS Baby 1.5 Bioabsorbable Fixation System, Inion, Ltd. (2001) Summary page 5.
- K033194: Inion CPS Baby 1.5 Bioabsorbable System, Inion, Ltd. (2003) Summary page 5.

## Indications for use
The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures in the mid-face and maxilla of infant (from 29 days to 2 years of age) and child (greater than 2 years to 12 years of age) patients. Specific indications: - congenital anomalies correction in the orbital rim, orbital floor, maxilla and midface - traumatic injuries. 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 orbital floor, medial and lateral orbital walls, orbital rim, mid-face, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) of child (greater than 2 years to 12 years of age), adolescent (greater than 12 years through 21 years of age) and adult patients. Specific indications: fixation of LeFort (I, II, III) osteotomies and mandibular orthognathic procedures.

Source page: https://510kreport.com/device/K251441
Methodology: https://510kreport.com/methodology