# K063410: Inion CPS/Otps Freedomplate

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Jan 23, 2007 after 71 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K974017 (1998). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 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)
- K023887: Inion Otps Biodegradable Mini Plating System, Inion, Ltd. (2003) Summary page 1.
- K031961: Inion Otps Biodegradable Mesh Plating System, Inion, Ltd. (2004) Summary page 1.

## Most influential descendants
- K081588: RE-Zorb Plating System (2008), 1 descendant of its own
- K120163: Acute Innovations Biobridge Resorbable Plating System (2012), 0 descendants of its own

## Indications for use
A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures. B. Specific indications: 1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible 2. Metacarpus, proximal and middle phalangeal bones 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Source page: https://510kreport.com/device/K063410
Methodology: https://510kreport.com/methodology