Cleared Special

K171794 - Smith & Nephew 25 Fluid Management System

K171794 is an FDA 510(k) clearance for Smith & Nephew 25 Fluid Management System, 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 11-day FDA review.

K171794 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
11d
Days
Class 2
Risk

K171794 is an FDA 510(k) clearance for the Smith & Nephew 25 Fluid Management 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 June 27, 2017 after a review of 11 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 - K171794

510(k) Number K171794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2017
Decision Date June 27, 2017
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
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 K171794.
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
K172116 · Stryker Corporation · Jan 2018
FMS VUE II Fluid Management and Tissue Debridement System
K171237 · Medos International SARL · Jan 2018
Reprocessed Shavers/Burs
K172092 · Renovo, Inc. · Oct 2017
JOINIX CANNULAR SYSTEM
K162070 · Aju Pharm Co., Ltd. · Mar 2017
Intra medullary endo-transilluminating device (iMET device)
K163037 · WeMED Bio-Tech, Inc. · Feb 2017
AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
K162062 · Stryker Corporation · Nov 2016
K171794 · Smith & Nephew 25 Fluid Management System
Download PDF FDA Summary Smith & Nephew, Inc.