510(k) Report

510(k) · Cleared

Cleared

INTELLIO SHIFT System

K232290510(k) TraditionalCleared Dec 11, 2023132-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

ArthroCare Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 11, 2023 as substantially equivalent to K210423 (ArthroCare Corporation, 2021) and 1 other predicate after a 132-day review. Its family tree reaches back 5 generations to 1996.

Decided
Dec 11, 2023
Review
132 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K954171 (1996). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2003: 2 other ancestors2002: 1 other ancestorK954171 · Arco-MBC, Arco MC · Holl Meditronics, Inc. · 1996K993265 · Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 · Soring GmbH Medizintechnik · 1999K024059 · MBC Series · Soring GmbH Medizintechnik · 2003K052859 · Aquamantys Pump Generator System · Tissuelink Medical, Inc. · 2005 · recalledK210423 · Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand · ArthroCare Corporation · 20211995200020052010201520202025
Other ancestors, by generation 1 generation back: 1 other ancestor3 generations back: 3 other ancestors K210423 · Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand · ArthroCare Corporation · 2021K052859 · Aquamantys Pump Generator System · Tissuelink Medical, Inc. · 2005 · recalledK024059 · MBC Series · Soring GmbH Medizintechnik · 2003K993265 · Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 · Soring GmbH Medizintechnik · 1999K954171 · Arco-MBC, Arco MC · Holl Meditronics, Inc. · 1996−50
  1. Root · 5 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
  2. 4 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
  3. 3 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
  4. 2 generations backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
  5. 1 generation backK210423 Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal…ArthroCare Corporation · 2021
  6. This deviceK232290 INTELLIO SHIFT SystemArthroCare Corporation · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K954171Arco-MBC, Arco MCHoll Meditronics, Inc.1996—
−4K993265Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik1999—
−3K024059MBC SeriesSoring GmbH Medizintechnik2003—
−2K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc.20051
−1K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0…ArthroCare Corporation2021—
0 (this device)K232290INTELLIO SHIFT SystemArthroCare Corporation2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200710
FIG. 1 — Lineage of K232290, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
Summary page 5
…LF+ COBLATION System The INTELLIO SHIFT System is substantially equivalent to the WEREWOLF+ COBLATION System, cleared by the FDA under the Premarket Notification K210423. 4) Reference Predicate Device: DYONICS POWER II Control System The INTELLIO SHIFT System is substantially equivalent to t…
ArthroCare Corporation2021—
*K062849Smith & Nephew Duonics Power II Shaver System
Summary page 5
…Control System The INTELLIO SHIFT System is substantially equivalent to the DYONICS POWER II Control System, cleared by the FDA under the Premarket Notification K062849. 5) Intended Use of INTELLIO SHIFT System The INTELLIO SHIFT System is intended for:  Resection, ablation, and coagul…
Smith & Nephew, Inc.2007—

Also cleared against K210423: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
  • 3 of the 9 ancestors have a recall of any class.
  • 1 other device also cites its predicate K210423.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

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…

Read the full statement (95 words)

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

Indications for use as stated in the FDA summary.

Also cleared against K210423

1 other device cites the same predicate.

  • K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+…ArthroCare Corporation · 2023

More from ArthroCare Corporation

37 FDA decisions under this applicant name. See the company

  • K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
  • K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation · 2026
  • K240964FLOW 90? WandArthroCare Corporation · 2024
  • K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+…ArthroCare Corporation · 2023
  • K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System…ArthroCare Corporation · 2022

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https://510kreport.com/device/K232290 · printed Nov 5, 2026

Cite this page

510(k) Report. “K232290: INTELLIO SHIFT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232290

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026