Cleared Traditional

K043395 - SMITH & NEPHEW VIDEOARTHROSCOPE

K043395 is the FDA 510(k) clearance for SMITH & NEPHEW VIDEOARTHROSCOPE by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K043395 · Smith & Nephew, Inc. · Orthopedic device
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Jan 2005
Decision
33d
Days
Class 2
Risk

K043395 is an FDA 510(k) clearance for the SMITH & NEPHEW VIDEOARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on January 12, 2005 after a review of 33 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.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K043395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2004
Decision Date January 12, 2005
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 K043395.
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K043568 · Medtronic Sofamor Danek · Jan 2005
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · Medtronic Sofamor Danek, Inc. · Jul 2004
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
K041135 · Depuy Mitek, A Johnson & Johnson Company · May 2004
LINVATEC 10K IRRIGATION SYSTEM
K033573 · Linvatec Corp. · Feb 2004