Cleared Special

K021502 - OSCAR, MODEL OE3000

K021502 is an FDA 510(k) clearance for OSCAR, manufactured by Orthosonics, Ltd.. The device is a Class 2 Orthopedic device with product code LZV cleared through the Special 510(k) pathway after a 28-day FDA review.

K021502 · Orthosonics, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
28d
Days
Class 2
Risk

K021502 is an FDA 510(k) clearance for the OSCAR, MODEL OE3000. Classified as System, Cement Removal Extraction (product code LZV), Class II - Special Controls.

Submitted by Orthosonics, Ltd. (Brookeville, US). The FDA issued a Cleared decision on June 6, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4580 - 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 - K021502

510(k) Number K021502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date June 06, 2002
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

LZV Device Classification - Class 2, Special Controls

Product Code LZV System, Cement Removal Extraction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
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.

K021502 · OSCAR, MODEL OE3000
Download PDF FDA Summary Orthosonics, Ltd.