# K123832: Oic Distal Radius Plating System, Oic Proximal Humerus Plating System, Oic Clavicle Plating System, the Oic Small Fragme

- Pathway: 510(k) (Traditional)
- Applicant: The Orthopaedic Implant Company (Oic)
- Decided: Mar 20, 2013 after 97 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
No predicates in its family tree.
6 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K202971: DRPx Locking Distal Radius Plate System (2021), 2 descendants of its own
- K140357: Oic Variable Angle Small Fragment Locking Plate System (2014), 2 descendants of its own
- K223118: OIC Variable Angle Small Fragment Locking Plate System (2023), 1 descendant of its own
- K242995: OIC Small / Mini Fragment Plate System (2024), 0 descendants of its own
- K233531: OIC FLEX-FIX™ System (2024), 0 descendants of its own

## Indications for use
a. Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and osteotomies of the distal radius. b. Clavicle Plates are indicated for the fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle. c. Proximal Humerus plates are Indicated for the fixcation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.

Source page: https://510kreport.com/device/K123832
Methodology: https://510kreport.com/methodology