# K020266: Inion CPS Bsso Screw

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Feb 22, 2002 after 28 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- 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

## Recalls of this device
- Apr 14, 2010 · Not classified · Z-0630-2011: Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
- Apr 14, 2010 · Not classified · Z-0631-2011: Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
- Mar 5, 2010 · Not classified · Z-1550-2010: During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.

## Indications for use
Indications: A. General indications: The Inion CPS™ BSSO Screw 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.

Source page: https://510kreport.com/device/K020266
Methodology: https://510kreport.com/methodology