# K242995: OIC Small / Mini Fragment Plate System

- Pathway: 510(k) (Special)
- Applicant: The Orthopaedic Implant Company
- Decided: Oct 23, 2024 after 27 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: 12 generations back to K962616 (1996). 180 ancestors in all.
No later device cites it as a predicate yet.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223118: OIC Variable Angle Small Fragment Locking Plate System, Orthopaedic Implant Company (2023) Summary page 5.
- K171904: Tandry Locking Plate System, Microware Precision Co., Ltd. (2018) Summary page 5.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 5.
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2012) Summary page 5.
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.

## Indications for use
The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

Source page: https://510kreport.com/device/K242995
Methodology: https://510kreport.com/methodology