Cleared Traditional

SIGN IM NAIL (K013132) - FDA 510(k) Clearance

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

K013132 · Surgical Implant Generation Network (Sign) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
92d
Days
Class 2
Risk

K013132 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 December 20, 2001 after a review of 92 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 Surgical Implant Generation Network (Sign) devices

Submission Details

510(k) Number K013132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2001
Decision Date December 20, 2001
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 K013132.
GAMMA 3 LAG SCREW
K020677 · Howmedica Osteonics Corp. · Mar 2002
T2 FEMORAL NAIL SYSTEM
K014220 · Howmedica Osteonics Corp. · Jan 2002
LONG TROCHANTERIC NAIL SYSTEM
K013563 · DePuy Orthopaedics, Inc. · Dec 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · DePuy Orthopaedics, Inc. · Dec 2001
LONG LENGTH DYAX NAIL
K013468 · Howmedica Osteonics Corp. · Nov 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · Howmedica Osteonics Corp. · Nov 2001