Cleared Traditional

EXOJET TISSUE MANAGEMENT SYSTEM (K031406) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031406 · Mitek Worldwide · Orthopedic device
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May 2003
Decision
25d
Days
Class 2
Risk

K031406 is an FDA 510(k) clearance for the EXOJET TISSUE MANAGEMENT SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Mitek Worldwide (Norwood, US). The FDA issued a Cleared decision on May 30, 2003 after a review of 25 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mitek Worldwide devices

Submission Details

510(k) Number K031406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date May 30, 2003
Days to Decision 25 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K031406.
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · Smith & Nephew, Inc. · Jan 2005
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
K030082 · Richard Wolf Medical Instruments Corp. · Oct 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · Smith & Nephew, Inc. · Jun 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291 · Arthrex, Inc. · Mar 2003
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
K030096 · Arthrex, Inc. · Mar 2003
DYONICS POWER CONTROL UNIT
K030196 · Smith & Nephew, Inc. · Feb 2003