# K033194: Inion CPS Baby 1.5 Bioabsorbable System

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Oct 30, 2003 after 28 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 K010351 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite 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.

## Most influential descendants
- K251441: Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (2025), 0 descendants of its own
- 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
Indications: A. General indications: The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface and maxilla. B. Specific indications: Fractures of the cranium, midface and maxilla. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations). LeFort (I, 11, 111) osteotomies. Pediatric reconstructive procedures. Orthognathic or reconstructive procedures of the cranium, midface or maxilla. Craniotomy flap fixation. Contraindications: The Inion CPS Baby 1.5 Bioabsorbable Fixation System is not intended for use in and is contraindicated for: 1. Mandibular tumor resection. 2. Active or potential infection. 3. Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed. (e.g., alcoholism, drug abuse) 4. DO NOT USE in the mandible.

Source page: https://510kreport.com/device/K033194
Methodology: https://510kreport.com/methodology