Cleared Traditional

K082754 - AEQUALIS HUMERAL NAIL SYSTEM

K082754 is an FDA 510(k) clearance for AEQUALIS HUMERAL NAIL SYSTEM, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K082754 · Tornier · Orthopedic device
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Jan 2009
Decision
130d
Days
Class 2
Risk

K082754 is an FDA 510(k) clearance for the AEQUALIS HUMERAL NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Tornier (Warsaw, US). The FDA issued a Cleared decision on January 27, 2009 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Tornier devices

FDA 510(k) Submission Details - K082754

510(k) Number K082754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2008
Decision Date January 27, 2009
Days to Decision 130 days
Submission Type Traditional
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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K082754.
AOS PROXIMAL HUMERAL NAIL
K090478 · Advanced Orthopaedic Solutions, Inc. · Mar 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · OrthoPediatrics Corp. · Mar 2009
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
K083497 · Zimmer, Inc. · Feb 2009
MODIFICATION TO T2 RECON NAIL SYSTEM
K083437 · Howmedica Osteonics Corp. · Dec 2008
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
K082770 · Zimmer, Inc. · Dec 2008
T2 FLEXIBLE NAIL
K082018 · Howmedica Osteonics Corp. · Oct 2008