Cleared Traditional

K062849 - SMITH & NEPHEW DUONICS POWER II SHAVER ...

K062849 is the FDA 510(k) clearance for SMITH & NEPHEW DUONICS POWER II SHAVER ... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K062849 · Smith & Nephew, Inc. · Orthopedic device
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Jan 2007
Decision
116d
Days
Class 2
Risk

K062849 is an FDA 510(k) clearance for the SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM. 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 19, 2007 after a review of 116 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K062849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date January 19, 2007
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 K062849.
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
K080617 · Richard Wolf Medical Instruments Corp. · Jun 2008
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K072879 · Biomet Orthopedics, Inc. · Jan 2008
SMITH & NEPHEW ARTHROSCOPE
K072675 · Smith & Nephew, Inc. · Oct 2007
MODIFICATION TO ENDIUS ATAVI SYSTEM
K061345 · Endius, Inc. · Jun 2006
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
K060198 · Linvatec Corp. · May 2006
ATHROCARE TOPAZ ARTHROWANDS
K053567 · Arthrocare Corp. · Mar 2006