Cleared Traditional

K940230 - ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS

K940230 is an FDA 510(k) clearance for ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS, manufactured by Instratek, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K940230 · Instratek, Inc. · Orthopedic device
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Dec 1994
Decision
332d
Days
Class 2
Risk

K940230 is an FDA 510(k) clearance for the ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Instratek, Inc. (Houston, US). The FDA issued a Cleared decision on December 12, 1994 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Instratek, Inc. devices

FDA 510(k) Submission Details - K940230

510(k) Number K940230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1994
Decision Date December 12, 1994
Days to Decision 332 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 122d · This submission: 332d
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 456
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K940230.
CTS RELIEF KIT
K941651 · Linvatec Corp. · Jan 1995
THE KARL STORZ ARTHROPUMP
K942298 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
TRANSTIBIAL ACL DISPOSABLES KIT
K943943 · Arthrex, Inc. · Dec 1994
KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
K943154 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES
K943323 · Stryker Corp. · Nov 1994
MENISCAL SUTURE INSTRUMENTARIUM
K940287 · Richard Wolf Medical Instruments Corp. · Nov 1994