# K133932: Inion Freedompin

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Apr 11, 2014 after 109 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 3 generations back to K901456 (1990). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050275: Modification to: Inion Otps Biodegradable Pin, Inion, Ltd. (2005) Summary page 1.

## Most influential descendants
- K250646: Impact PEEK Union Nail System (2025), 3 descendants of its own
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own
- K252657: Impact PEEK Union Nail System (2025), 0 descendants of its own

## Indications for use
The INION FreedomPlum products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Source page: https://510kreport.com/device/K133932
Methodology: https://510kreport.com/methodology