# K051341: Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058 and PLT-1059

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: May 27, 2005 after 4 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 K971870 (1997). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 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.
- K992355: Lactosorb Trauma Plating System, Biomet, Inc. (1999) Summary page 1.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.

## Most influential descendants
- K070737: Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories (2007), 1 descendant 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
- K072528: Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & Accessories (2007), 0 descendants of its own

## Indications for use
A. General indications: The INION CPSTM I BABY 1.5 BIOABSORBABLE 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 (1,11, 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/K051341
Methodology: https://510kreport.com/methodology