# K013039: Inion CPS 2.0 Orthognathic Plate

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Oct 5, 2001 after 25 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 K010352 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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 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

## Indications for use
Indications: A. General indications: The Inion CPS™ 2.0 Orthognathic Plate is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System. B. Specific indications: Fractures of the cranium, midface, maxilla and mandible. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations). LeFort (I, II, III) osteotomies. Pediatric reconstructive procedures. Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible. Craniotomy flap fixation. Contraindications: The Inion CPS™ 2.0 Orthognathic Plate 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 without appropriate maxillomandibular fixation.

Source page: https://510kreport.com/device/K013039
Methodology: https://510kreport.com/methodology