Cleared Traditional

SIGN IM NAIL (K022632) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022632 · Surgical Implant Generation Network (Sign) · Orthopedic device
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Sep 2002
Decision
47d
Days
Class 2
Risk

K022632 is an FDA 510(k) clearance for the SIGN IM NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Surgical Implant Generation Network (Sign) (Richland, US). The FDA issued a Cleared decision on September 23, 2002 after a review of 47 days - a notably fast clearance cycle.

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: 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 Surgical Implant Generation Network (Sign) devices

Submission Details

510(k) Number K022632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2002
Decision Date September 23, 2002
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K022632.
GAMMA 3 NAIL SYSTEM
K032244 · Howmedica Osteonics Corp. · Aug 2003
ACE VERSANAIL
K023115 · DePuy Orthopaedics, Inc. · Dec 2002
T2 SUPRACONDYLAR NAIL SYSTEM
K023267 · Howmedica Osteonics Corp. · Dec 2002
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · Biomet, Inc. · Aug 2002
S2 TIBIAL NAIL
K022481 · Howmedica Osteonics Corp. · Aug 2002
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002