Cleared Traditional

K043395 - SMITH & NEPHEW VIDEOARTHROSCOPE

K043395 is an FDA 510(k) clearance for SMITH & NEPHEW VIDEOARTHROSCOPE, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K043395

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.

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 524
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K043395.
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
K051326 · Smith & Nephew, Inc. · Jun 2005
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K050580 · Smith & Nephew Endoscopy, Inc. · Apr 2005
EQUESTRA FLUID DELIVERY SYSTEM
K043568 · Medtronic Sofamor Danek · Jan 2005
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
K041824 · Future Medical Systems, SA · Jan 2005
ARTHROJET XT
K041233 · Hydrocision, Inc. · Jul 2004
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · Medtronic Sofamor Danek, Inc. · Jul 2004