Cleared Traditional

K173311 - ARTHRO-Pump PA304

K173311 is the FDA 510(k) clearance for ARTHRO-Pump PA304 by W.O.M. World of Medicine GmbH. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K173311 · W.O.M. World of Medicine GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
203d
Days
Class 2
Risk

K173311 is an FDA 510(k) clearance for the ARTHRO-Pump PA304. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on May 9, 2018 after a review of 203 days - an extended review 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: 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 W.O.M. World of Medicine GmbH devices

Submission Details

510(k) Number K173311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2017
Decision Date May 09, 2018
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K173311.
Endiscope, Endiscope Cervical
K180766 · Elliquence, LLC · Jun 2018
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DTRAX Spinal System
K180876 · Providence Medical Technology, Inc. · May 2018
DISKOM
K180315 · Biopsybell S.R.L. · Mar 2018
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