Cleared Traditional

K950130 - MICRO-ENDO(TM) INSTRUMENTS

K950130 is an FDA 510(k) clearance for MICRO-ENDO(TM) INSTRUMENTS, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K950130 · Sofamor Danek USA,Inc. · Orthopedic device
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May 1995
Decision
109d
Days
Class 2
Risk

K950130 is an FDA 510(k) clearance for the MICRO-ENDO(TM) INSTRUMENTS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on May 1, 1995 after a review of 109 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K950130

510(k) Number K950130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1995
Decision Date May 01, 1995
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 413
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K950130.
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS
K946151 · Depuy, Inc. · May 1995
1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE
K950705 · Neuro Navigational Corp. · May 1995
2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE
K940483 · Neuro Navigational Corp. · May 1995
ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
K941709 · Acufex Microsurgical, Inc. · Apr 1995
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K943450 · Arthrocare Corp. · Mar 1995
ARTHROSCOPE ACCESSORIES
K944210 · Stryker Endoscopy · Feb 1995