Cleared Traditional

K170482 - Spider Frame External Fixation System

K170482 is an FDA 510(k) clearance for Spider Frame External Fixation System, manufactured by Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K170482 · Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
223d
Days
Class 2
Risk

K170482 is an FDA 510(k) clearance for the Spider Frame External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S (Istanbul, TR). The FDA issued a Cleared decision on September 27, 2017 after a review of 223 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 Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S devices

FDA 510(k) Submission Details - K170482

510(k) Number K170482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2017
Decision Date September 27, 2017
Days to Decision 223 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 122d · This submission: 223d
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 313
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K170482.
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