# K010351: Inion CPS Baby 1.5 Bioabsorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Mar 15, 2001 after 37 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051341: Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058 and PLT-1059 (2005), 3 descendants of its own
- K033194: Inion CPS Baby 1.5 Bioabsorbable System (2003), 2 descendants of its own
- K070737: Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories (2007), 1 descendant of its own
- K052444: Inion CPS Baby 1.5 Bioabsorbable Fixation System (2005), 1 descendant of its own
- 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.

Source page: https://510kreport.com/device/K010351
Methodology: https://510kreport.com/methodology