Cleared Traditional

K083830 - OSCAR BONE RESECTOR

K083830 is an FDA 510(k) clearance for OSCAR BONE RESECTOR, manufactured by Orthosonics, Ltd.. The device is a Class 2 Orthopedic device with product code JDX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K083830 · Orthosonics, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
87d
Days
Class 2
Risk

K083830 is an FDA 510(k) clearance for the OSCAR BONE RESECTOR. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Orthosonics, Ltd. (Ashburton, Devon, GB). The FDA issued a Cleared decision on March 20, 2009 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthosonics, Ltd. devices

FDA 510(k) Submission Details - K083830

510(k) Number K083830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2008
Decision Date March 20, 2009
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDX Device Classification - Class 2, Special Controls

Product Code JDX Instrument, Surgical, Sonic And Accessory/attachment
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.

Regulatory Peers - JDX Instrument, Surgical, Sonic And Accessory/attachment

All 8
Devices cleared under the same product code (JDX) and FDA review panel - the closest regulatory comparables to K083830.
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