Cleared Traditional

K082095 - ULTRASLIDE ACROMIOCLAVICULAR AND SYNDES...

K082095 is the FDA 510(k) clearance for ULTRASLIDE ACROMIOCLAVICULAR AND SYNDES... by Smith & Nephew Endoscopy, Inc.. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K082095 · Smith & Nephew Endoscopy, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2008
Decision
89d
Days
Class 2
Risk

K082095 is an FDA 510(k) clearance for the ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Smith & Nephew Endoscopy, Inc. (Andover, US). The FDA issued a Cleared decision on October 21, 2008 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Smith & Nephew Endoscopy, Inc. devices

Submission Details

510(k) Number K082095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2008
Decision Date October 21, 2008
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HTN Washer, Bolt Nut

All 66
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K082095.
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