Cleared Traditional

K031875 - INTER-OS LIMB LENGTHENER

K031875 is an FDA 510(k) clearance for INTER-OS LIMB LENGTHENER, manufactured by Inter-Os Technologies. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K031875 · Inter-Os Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
127d
Days
Class 2
Risk

K031875 is an FDA 510(k) clearance for the INTER-OS LIMB LENGTHENER. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Inter-Os Technologies (Lone Tree, US). The FDA issued a Cleared decision on October 22, 2003 after a review of 127 days - within the typical 510(k) review window.

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 Inter-Os Technologies devices

FDA 510(k) Submission Details - K031875

510(k) Number K031875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2003
Decision Date October 22, 2003
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 340
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K031875.
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635 · Ebi, L.P. · Dec 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
K033411 · Synthes (Usa) · Nov 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · Synthes (Usa) · Nov 2003
EBI XFIX DFS SYSTEM
K031919 · Ebi, L.P. · Sep 2003
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
K032058 · Alliance Medical Corp. · Jul 2003
EXTERNAL FIXATION SYSTEMS
K031181 · Smith & Nephew, Inc. · Jul 2003