# K222753: SeaSpine 7D Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Dec 9, 2022 after 88 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: 5 generations back to K050438 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K192140: 7D Surgical System, 7D Surgical, Inc. (2019) Summary page 4.
- K162375: Envision 3D: Image Guidance System, 7D Surgical, Inc. (2016) Summary page 4.

## Most influential descendants
- K243659: FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (2025), 0 descendants of its own

## Indications for use
The SeaSpine 7D Navigation Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are specifically designed for use with the 7D Surgical System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K222753
Methodology: https://510kreport.com/methodology