# K243659: FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Apr 2, 2025 after 126 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: 21 generations back to K003155 (2001). 335 ancestors in all.
No later device cites it as a predicate yet.
4 of 336 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222753: SeaSpine 7D Navigation Instruments, SeaSpine Orthopedics Corporation (2022) Summary page 5.
- K240625: CORUS Navigation Access System, Providence Medical Technology, Inc. (2024) Summary page 5.

## Indications for use
The FLASH™ Facet Fusion Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating and preparing anatomical structures, specifically the lumbar facet joints, in either open or minimally invasive procedures. The FLASH™ Facet Fusion 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. The IsoTis® Facet Fusion Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating and preparing anatomical structures, specifically the lumbar facet joints, in either open or minimally invasive procedures. The IsoTis® Facet Fusion 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/K243659
Methodology: https://510kreport.com/methodology