Cleared Traditional

K013132 - SIGN IM NAIL

K013132 is an FDA 510(k) clearance for SIGN IM NAIL, manufactured by Surgical Implant Generation Network (Sign). The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K013132

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.

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 395
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K013132.
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
K013923 · Biomet Orthopedics, Inc. · Feb 2002
T2 FEMORAL NAIL SYSTEM
K014220 · Howmedica Osteonics Corp. · Jan 2002
LONG TROCHANTERIC NAIL SYSTEM
K013563 · DePuy Orthopaedics, Inc. · Dec 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
K013449 · Disc-O-Tech Medical Technologies, Ltd. · Dec 2001
POLARUS CAP SCREW
K013616 · Acu Med, Inc. · Dec 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · DePuy Orthopaedics, Inc. · Dec 2001