Cleared Traditional

K233675 - FMS VUE Fluid Management and Tissue Deb...

K233675 is an FDA 510(k) clearance for FMS VUE Fluid Management and Tissue Deb..., manufactured by DePuy Mitek, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K233675 · DePuy Mitek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
102d
Days
Class 2
Risk

K233675 is an FDA 510(k) clearance for the FMS VUE™ Fluid Management and Tissue Debridement System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by DePuy Mitek, Inc. (Raynham, US). The FDA issued a Cleared decision on February 26, 2024 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all DePuy Mitek, Inc. devices

FDA 510(k) Submission Details - K233675

510(k) Number K233675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2023
Decision Date February 26, 2024
Days to Decision 102 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 423
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K233675.
MIDASVu
K243020 · Intravu, Inc. · Dec 2024
Vertos mild Device Kit (MDK-0002)
K233800 · Vertos Medical, Inc. · May 2024
Digital ClarusScope System
K240535 · Clarus Medical, LLC · Apr 2024
Hawkeye Control Unit with Eyas Endoscope
K233115 · E Surgical, LLC · Feb 2024
Kyphoplasty Balloon Catheter
K223709 · Jiangsu Changmei Medtech Co., Ltd. · Aug 2023
Kyphoplasty Balloon System
K221142 · OK Medinet Korea Co., Ltd. · Apr 2023