# K052624: Inion Otps Biodegradable Distal Radius Plate

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Nov 16, 2005 after 54 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 K792022 (1979). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020819: Distal Radius Plating System, Biomet, Inc. (2002) Summary page 1.

## Indications for use
The INION OTPSTm BIODEGRADABLE DISTAL RADIUS PLATE implants are indicated for use in open reduction and internal fixation of fractures, osteotomies, and radiolunocarpal fusion of the distal radius in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K052624
Methodology: https://510kreport.com/methodology