# K023887: Inion Otps Biodegradable Mini Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: May 30, 2003 after 190 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: 1 generation back to K991763 (1999). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992301: Reunite Screws, Biomet Manufacturing, Inc. (1999) Summary page 1.
- K991763: Lactosorb Hand System, Biomet, Inc. (1999) Summary page 1.
- (no number) Synthes Compact Hand 1.0/1.3: named in the summary without a submission number

## Most influential descendants
- K063410: Inion CPS/Otps Freedomplate (2007), 2 descendants of its own
- K081588: RE-Zorb Plating System (2008), 1 descendant of its own
- K120163: Acute Innovations Biobridge Resorbable Plating System (2012), 0 descendants of its own
- K050388: Refix Internal Fracture Fixation Screws (2005), 0 descendants of its own

## Indications for use
The Inion OTPSTMBiodegradable Mini Plating System is intended for use in fixation of non-comminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K023887
Methodology: https://510kreport.com/methodology