Cleared Traditional

K051678 - SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM

K051678 is the FDA 510(k) clearance for SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K051678 · Synthes (Usa) · Orthopedic device
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Sep 2005
Decision
90d
Days
Class 2
Risk

K051678 is an FDA 510(k) clearance for the SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on September 21, 2005 after a review of 90 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 Synthes (Usa) devices

Submission Details

510(k) Number K051678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2005
Decision Date September 21, 2005
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K051678.
S2 RECON NAIL SYSTEM
K060921 · Howmedica Osteonics Corp. · Apr 2006
ORTHOFIX TITANIUM NAILING SYSTEMS
K053261 · Orthofix Srl · Dec 2005
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP
K053105 · Synthes (Usa) · Dec 2005
T2 ANKLE ARTHRODESIS NAIL
K051590 · Howmedica Osteonics Corp. · Jul 2005
T2 RECON NAIL SYSTEM
K051624 · Howmedica Osteonics Corp. · Jul 2005
GAMMA3 NAIL SYSTEM
K043431 · Howmedica Osteonics Corp. · Feb 2005