Cleared Traditional

INCLUSICE II(TM) ENDOSCOPE (K946087) - FDA 510(k) Clearance

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

K946087 · Sofamor Danek USA,Inc. · Orthopedic device
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Nov 1995
Decision
343d
Days
Class 2
Risk

K946087 is an FDA 510(k) clearance for the INCLUSICE II(TM) ENDOSCOPE. 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 November 21, 1995 after a review of 343 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 Sofamor Danek USA,Inc. devices

Submission Details

510(k) Number K946087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date November 21, 1995
Days to Decision 343 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
221d slower than avg
Panel avg: 122d · This submission: 343d
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 K946087.
KARL STORZ TARGETING UNIT
K955652 · KARL STORZ Endoscopy-America, Inc. · Jan 1996
KARL STORZ HEMPFLING DILATION SET
K954981 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
K955272 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · Richard Wolf Medical Instruments Corp. · Sep 1995
UNIMAT PUMP
K953075 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
CO2 ARTHROFLATOR
K953550 · KARL STORZ Endoscopy-America, Inc. · Aug 1995