Cleared Traditional

K926111 - ARTHROSCOPIC KNEE INSTRUMENTS

K926111 is the FDA 510(k) clearance for ARTHROSCOPIC KNEE INSTRUMENTS by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K926111 · Arthrex, Inc. · Orthopedic device
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Mar 1993
Decision
103d
Days
Class 2
Risk

K926111 is an FDA 510(k) clearance for the ARTHROSCOPIC KNEE INSTRUMENTS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 103 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 Arthrex, Inc. devices

Submission Details

510(k) Number K926111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date March 16, 1993
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 122d · This submission: 103d
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 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K926111.
SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST.
K924017 · Symbiosis Corp. · Mar 1993
ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES
K925996 · Arthrex, Inc. · Mar 1993
ARTHROSCOPIC KNEE INSTRUMENTS
K926062 · Arthrex, Inc. · Mar 1993
ARTHREX INSTRUMENTS (SHOULDER GP. 1)
K926193 · Arthrex, Inc. · Mar 1993
ARTHROSCOPIC INSTRUMENTS
K925456 · Arthrex, Inc. · Mar 1993
ARTHREX BAYONET KNIFE
K925457 · Arthrex, Inc. · Mar 1993