# K232290: INTELLIO SHIFT System

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Dec 11, 2023 after 132 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K954171 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210423: Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand, ArthroCare Corporation (2021) Summary page 5.
- K062849: Smith & Nephew Duonics Power II Shaver System, Smith & Nephew, Inc. (2007) Summary page 5.

## Indications for use
The INTELLIO SHIFT System is indicated for: -Resection of soft and osseous tissues -Resection, Ablation and Coagulation of soft tissue and hemostasis of blood vessels during the following arthroscopic and orthopedic procedures: •Articular Cartilage •Bursectomy •Chondroplasty •Fascia •Ligament •Scar Tissue •Soft Tissue •Synovectomy •Tendon •Articular Labrum •Capsule •Cysts •Ligament •Loose Bodies •Plica Removal •Scar Tissue •Soft Tissue •Synovial Membrane •Tendon •Acetabular Labrum •ACL/PCL •Notchplasty •Capsular Release •Cartilage Flaps •Discoid Meniscus •Lateral Release •Meniscal Cystectomy •Meniscectomy •Villusectomy •Acromioplasty •Subacromial Decompression •Frozen Shoulder Release •Glenoid Labrum •Triangular Fibrocartilage (TFCC) •Hemostasis (via Coagulation) of soft tissue and bone

Source page: https://510kreport.com/device/K232290
Methodology: https://510kreport.com/methodology