Cleared Special

K072675 - SMITH & NEPHEW ARTHROSCOPE

K072675 is an FDA 510(k) clearance for SMITH & NEPHEW ARTHROSCOPE, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 24-day FDA review.

K072675 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
24d
Days
Class 2
Risk

K072675 is an FDA 510(k) clearance for the SMITH & NEPHEW ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on October 15, 2007 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072675

510(k) Number K072675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date October 15, 2007
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K072675.
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
K070021 · Jg Medical Products, LLC · Dec 2007
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006
K070874 · Arthro Kinetics, Inc. · Nov 2007
MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
K072706 · Conmed Linvatec · Oct 2007
CONMED LINVATEC SMART GUARD IRRIGATOR
K070233 · Conmed Linvatec · Apr 2007
CONMED LINVATEC 24K IRRIGATION SYSTEM
K063326 · Conmed Linvatec · Jan 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · Smith & Nephew, Inc. · Jan 2007
K072675 · SMITH & NEPHEW ARTHROSCOPE
Download PDF FDA Summary Smith & Nephew, Inc.