# K203105: Inion CompressOn Screw

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Jan 13, 2021 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K792022 (1979). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew), Inion OY (2013) Summary page 4.

## Indications for use
The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace). In addition, the Inion CompressOn™ Ø 3.5/4.0/4.5/5.0/6.0 mm products are specifically intended for use in following indications: A. General indication: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization. B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.

Source page: https://510kreport.com/device/K203105
Methodology: https://510kreport.com/methodology