Cleared Traditional

K171211 - OIC External Fixation System

K171211 is an FDA 510(k) clearance for OIC External Fixation System, manufactured by Orthopaedic Implant Company. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K171211 · Orthopaedic Implant Company · Orthopedic device
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Sep 2017
Decision
155d
Days
Class 2
Risk

K171211 is an FDA 510(k) clearance for the OIC External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Orthopaedic Implant Company (Reno, US). The FDA issued a Cleared decision on September 27, 2017 after a review of 155 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 Orthopaedic Implant Company devices

FDA 510(k) Submission Details - K171211

510(k) Number K171211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2017
Decision Date September 27, 2017
Days to Decision 155 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
33d slower than avg
Panel avg: 122d · This submission: 155d
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 304
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K171211.
ARBOR External Fixation System
K172438 · Globus Medical, Inc. · Jan 2018
Medline ReNewal Reprocessed Synthes External Fixation Systems
K171911 · Surgical Instrument Service and Savings, Inc. · Nov 2017
Galaxy UNYCO System
K170146 · Orthofix Srl · Oct 2017
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
K170650 · Orthofix Srl · May 2017
Hoffmann LRF System
K163656 · Stryker GmbH · Apr 2017
Hoffman LRF System
K161753 · Stryker GmbH · Nov 2016