Cleared Traditional

K881792 - CANNULA MODEL AR-6551

K881792 is an FDA 510(k) clearance for CANNULA MODEL AR-6551, manufactured by Arthrex Arthroscopy Instruments, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K881792 · Arthrex Arthroscopy Instruments, Inc. · Orthopedic device
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Jul 1988
Decision
72d
Days
Class 2
Risk

K881792 is an FDA 510(k) clearance for the CANNULA MODEL AR-6551. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrex Arthroscopy Instruments, Inc. (Norwalk, US). The FDA issued a Cleared decision on July 7, 1988 after a review of 72 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.

FDA 510(k) Submission Details - K881792

510(k) Number K881792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date July 07, 1988
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
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 665
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K881792.
EDWARDS ARTHROSCOPIC LEG HOLDER
K884302 · Baxter Healthcare Corp · Nov 1988
28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES
K881715 · KARL STORZ Endoscopy-America, Inc. · Aug 1988
3M CARPAL TUNNEL
K881703 · 3M Company · Jul 1988
HERMAN CANNULA SET
K880203 · Orthopedic Systems, Inc. · Apr 1988
TENDON HARVESTER
K880414 · Concept, Inc. · Mar 1988
MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG
K874911 · Walter Lorenz Surgical, Inc. · Feb 1988
K881792 · CANNULA MODEL AR-6551
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