Cleared Traditional

K921119 - ARTHREX ARTHROSCOPE

K921119 is the FDA 510(k) clearance for ARTHREX ARTHROSCOPE by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 767-day FDA review.

K921119 · Arthrex, Inc. · Orthopedic device
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Apr 1994
Decision
767d
Days
Class 2
Risk

K921119 is an FDA 510(k) clearance for the ARTHREX ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 767 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K921119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date April 15, 1994
Days to Decision 767 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
645d slower than avg
Panel avg: 122d · This submission: 767d
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 K921119.
ACUFEX ARTHROSCOPIC SUTURE CUTTER
K940506 · Acufex Microsurgical, Inc. · Apr 1994
ACUFEX SURETAC IXC SYSTEMS
K940623 · Acufex Microsurgical, Inc. · Apr 1994
ARTHROSCOPE, DISPOSABLE
K933576 · United States Surgical, A Division of Tyco Healthc · Apr 1994
LINVATEC POWERLINK SURGICAL SHAVING SYSTEM
K934379 · Linvatec Corp. · Apr 1994
SHAVER BLADE SET
K940075 · Arthrex, Inc. · Apr 1994
MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
K922519 · Smith & Nephew, Inc. · Mar 1994