Cleared Traditional

K173311 - ARTHRO-Pump PA304

K173311 is an FDA 510(k) clearance for ARTHRO-Pump PA304, manufactured by W.O.M. World of Medicine GmbH. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K173311

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.

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 523
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K173311.
Endiscope, Endiscope Cervical
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DISKOM
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K172116 · Stryker Corporation · Jan 2018
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K171237 · Medos International SARL · Jan 2018