# K233154: SkyOPS™ Orthopedic Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Sky Surgical, LLC
- Decided: Dec 21, 2023 after 85 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: 16 generations back to K954385 (1996). 249 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121437: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K170214: Additive Orthopaedics Locking Lattice Plate, Additive Orthopaedics, LLC (2017) Summary page 4.
- K010321: Modular Foot System - 2.7 MM Module, Synthes (Usa) (2001) Summary page 4.
- K221181: Treace Medical Concepts (TMC) Plating System, Treace Medical Concepts, Inc. (2023) Summary page 4.

## Most influential descendants
- K251732: Wrist Fracture System (2026), 0 descendants of its own

## Indications for use
The SkyOPS™ Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).

Source page: https://510kreport.com/device/K233154
Methodology: https://510kreport.com/methodology