Cleared Special

K030196 - DYONICS POWER CONTROL UNIT

K030196 is an FDA 510(k) clearance for DYONICS POWER CONTROL UNIT, 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 30-day FDA review.

K030196 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
30d
Days
Class 2
Risk

K030196 is an FDA 510(k) clearance for the DYONICS POWER CONTROL UNIT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on February 20, 2003 after a review of 30 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 - K030196

510(k) Number K030196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date February 20, 2003
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K030196.
KSEA POWERSHAVER SYSTEM S2
K030009 · Karl Storz Endoscopy · Apr 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291 · Arthrex, Inc. · Mar 2003
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
K030096 · Arthrex, Inc. · Mar 2003
DAVOL ARTHROVENT OUTFLOW TUBING
K030307 · Davol, Inc. · Feb 2003
SOHNIKS
K023783 · Sohniks Endoscopy, Inc. · Feb 2003
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
K023777 · Arthronet Medical, Inc. · Dec 2002
K030196 · DYONICS POWER CONTROL UNIT
Download PDF FDA Summary Smith & Nephew, Inc.