Cleared Traditional

K083582 - SIGN HIP CONSTRUCT (SHC), MODEL: 701

K083582 is an FDA 510(k) clearance for SIGN HIP CONSTRUCT (SHC), manufactured by Surgical Implant Generation Network (Sign). The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K083582 · Surgical Implant Generation Network (Sign) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
265d
Days
Class 2
Risk

K083582 is an FDA 510(k) clearance for the SIGN HIP CONSTRUCT (SHC), MODEL: 701. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Surgical Implant Generation Network (Sign) (Richland, US). The FDA issued a Cleared decision on August 26, 2009 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K083582

510(k) Number K083582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2008
Decision Date August 26, 2009
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 316
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K083582.
AFGHAN EXTERNAL FIXATOR
K092002 · Smith & Nephew, Inc. · Dec 2009
BIOMET VISION FOOTRING SYSTEM
K093057 · Ebi, L.P. · Dec 2009
HOFFMAN XPRESS LINE EXTENSION
K092834 · Howmedica Osteonics Corp. · Oct 2009
SMITH & NEPHEW RAIL SYSTEM
K090926 · Smith & Nephew, Inc. · Jun 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789 · DePuy Orthopaedics, Inc. · Mar 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636 · Sterilmed, Inc. · Mar 2009