# K010352: CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Mar 14, 2001 after 36 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 9 cite it directly.
0 of 14 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
- K061881: Osteotrans -MX Bioabsorbable Bone Fixation System (2007), 3 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K063410: Inion CPS/Otps Freedomplate (2007), 2 descendants of its own
- K122890: Inion CPS Orbital Plates (2013), 1 descendant of its own
- K081588: RE-Zorb Plating System (2008), 1 descendant 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.

Source page: https://510kreport.com/device/K010352
Methodology: https://510kreport.com/methodology