# K043142: Inion Otps Biodegradable Mini Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Feb 18, 2005 after 95 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 K992301 (1999). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 22 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.
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 1.

## Most influential descendants
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (2013), 17 descendants of its own
- 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

## Indications for use
These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone 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).

Source page: https://510kreport.com/device/K043142
Methodology: https://510kreport.com/methodology