# K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Feb 27, 2013 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: 5 generations back to K792022 (1979). 19 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031961: Inion Otps Biodegradable Mesh Plating System, Inion, Ltd. (2004) Summary page 1.
- K043142: Inion Otps Biodegradable Mini Plating System, Inion, Ltd. (2005) Summary page 1.
- K030900: Inion Otps Biodegradable Fixaton System, Inion, Ltd. (2003) Summary page 1.

## Most influential descendants
- K160304: OsteoBullet Compression Screw (2016), 8 descendants of its own
- K193660: OSSIOfiber™ Compression Screws (2020), 6 descendants of its own
- K221193: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (2022), 4 descendants of its own
- K213596: OSSIOfiber Compression Screw, 3.5mm (2021), 4 descendants of its own
- K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (2023), 3 descendants of its own

## Indications for use
The Inion FreedomScrewM products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomnies, arthrodeses or bone grafts (i.e., autografis or allografis) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace). In addition, the Inion FreedomScrewTM 03.5/4.0/4.5 mm products are specifically intended for use in following indications: A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomnies 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/K123672
Methodology: https://510kreport.com/methodology