Cleared Traditional

K163589 - SIGN IM Nail

K163589 is an FDA 510(k) clearance for SIGN IM Nail, manufactured by Sign Fracture Care International. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K163589 · Sign Fracture Care International · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
212d
Days
Class 2
Risk

K163589 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 Sign Fracture Care International (Richland, US). The FDA issued a Cleared decision on July 20, 2017 after a review of 212 days - an extended review 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: 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 Sign Fracture Care International devices

FDA 510(k) Submission Details - K163589

510(k) Number K163589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date July 20, 2017
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
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 379
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K163589.
Shotel Ankle Arthrodesis Nail System
K163627 · Biopro, Inc. · Sep 2017
PRECICE UNYTE System
K172061 · Nuvasive Specialized Orthopedics, Inc. · Aug 2017
Zimmer Natural Nail System
K172114 · Zimmer, Inc. · Aug 2017
PRECICE Intramedullary Limb Lengthening System
K170169 · Nuvasive Specialized Orthopedics, Inc. · Jun 2017
PRECICE UNYTE CoCr System
K162927 · Nuvasive Specialized Orthopedics, Inc. · Apr 2017
PRECICE Intramedullary Limb Lengthening System
K170346 · Nuvasive Specialized Orthopedics, Inc. · Mar 2017