# K052444: Inion CPS Baby 1.5 Bioabsorbable Fixation System

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Sep 20, 2005 after 14 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: 1 generation back to K982531 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010351: Inion CPS Baby 1.5 Bioabsorbable Fixation System, Inion, Ltd. (2001) Summary page 1.
- K982531: Howmedica Leibinger Resorbable Fixation System, Howmedica Corp. (1998) Summary page 1.

## Most influential descendants
- K251472: Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (2025), 0 descendants of its own

## Indications for use
A. General indications: Tile INION CPS BABY 1.5 B1OABSORBABLE FIXATION SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. B. Specific indications: •Fractures of the cranium, mid-face and maxilla *Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations) *LeFort (I, II, III) osteotomies *Pediatric reconstructive procedures *Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla *Craniotomy flap fixation

Source page: https://510kreport.com/device/K052444
Methodology: https://510kreport.com/methodology