Cleared Traditional

RADIONICS RF DISC CATHETER ELECTRODE SYSTEM (K001741) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001741 · Radionics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
137d
Days
Class 2
Risk

K001741 is an FDA 510(k) clearance for the RADIONICS RF DISC CATHETER ELECTRODE SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on October 23, 2000 after a review of 137 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 Radionics, Inc. devices

Submission Details

510(k) Number K001741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2000
Decision Date October 23, 2000
Days to Decision 137 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
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 162
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K001741.
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · KARL STORZ Endoscopy-America, Inc. · Jun 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · Aesculap, Inc. · Apr 2001
DYONICS CONTROL RF SYSTEM
K003572 · Smith & Nephew, Inc. · Feb 2001
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · KARL STORZ Endoscopy-America, Inc. · Sep 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · United States Surgical, A Division of Tyco Healthc · Aug 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · Smith & Nephew, Inc. · Jun 2000