Cleared Special

K022578 - ENDIUS FLEXTIP BLADE

K022578 is an FDA 510(k) clearance for ENDIUS FLEXTIP BLADE, manufactured by Endius, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 18-day FDA review.

K022578 · Endius, Inc. · Orthopedic device
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Aug 2002
Decision
18d
Days
Class 2
Risk

K022578 is an FDA 510(k) clearance for the ENDIUS FLEXTIP BLADE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Endius, Inc. (Plainville, US). The FDA issued a Cleared decision on August 23, 2002 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Endius, Inc. devices

FDA 510(k) Submission Details - K022578

510(k) Number K022578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2002
Decision Date August 23, 2002
Days to Decision 18 days
Submission Type Special
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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 413
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K022578.
DAVOL ARTHROVENT OUTFLOW TUBING
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K023187 · Karl Storz Endoscopy · Dec 2002
ENDIUS ATAVI SYSTEM
K022199 · Endius, Inc. · Oct 2002
ENDIUS ATAVI SYSTEM
K021748 · Endius, Inc. · Jun 2002
POWER TEK II
K020761 · Biomet, Inc. · Apr 2002
RESECTION ABLATOR
K013117 · Linvatec Corp. · Nov 2001