# K022981: Inion CPS 2.5/2.8 Screw

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Sep 12, 2002 after 3 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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
The Inion CPSTM2.5/2.8 Screws are 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 CPSTM1.5/2.0/2.5 Bioabsorbable Fixation System. Fractures of the cranium, midface, maxilla and mandible. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations). LeFort (1, 11, 111) osteotomies. Pediatric reconstructive procedures. Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible. Craniotomy flap fixation.

Source page: https://510kreport.com/device/K022981
Methodology: https://510kreport.com/methodology