# K220522: 7D Surgical System - Percutaneous Application (7D Flash Frame)

- Pathway: 510(k) (Special)
- Applicant: 7D Surgical
- Decided: May 20, 2022 after 86 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K210457 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210457: 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key, 7D Surgical, Inc. (2021) Summary page 5.

## Indications for use
The 7D Surgical System Percutaneous Application is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K220522
Methodology: https://510kreport.com/methodology