Cleared Traditional

K070021 - ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 (FDA 510(k) Clearance)

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

K070021 · Jg Medical Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
338d
Days
Class 2
Risk

K070021 is an FDA 510(k) clearance for the ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Jg Medical Products, LLC (Yonkers, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Jg Medical Products, LLC devices

Submission Details

510(k) Number K070021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date December 07, 2007
Days to Decision 338 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
216d slower than avg
Panel avg: 122d · This submission: 338d
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 679
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K070021.
Freedom DS™ Decompression System
K253523 · Spinal Simplicity · Apr 2026
VantageTM Lumbar Decompression Kit
K252546 · Allevion Medical, LLC · Mar 2026
MiiS Horus Arthroscope (EJA 100)
K253217 · Medimaging Integrated Solution, Inc (Miis) · Dec 2025
PUREVUE™ FMS
K250795 · W.O.M. World of Medicine GmbH · Dec 2025
Articulator Arthroscopic Bur
K252666 · Joint Preservation Innovations, LLC · Nov 2025
Kyphoplasty Balloon Dilatation Catheters
K252458 · Shanghai Lange Medtech Co., Ltd. · Nov 2025