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
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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.

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
Combination Product No
PCCP Authorized No
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 394
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
OIC External Fixation System
K171211 · Orthopaedic Implant Company · Sep 2017
The Locking Pediatric Osteotomy Plate (LolliPOP) System
K170704 · Pega Medical, Inc. · Sep 2017
DRACO Locking Bone Screws
K163486 · Hnm Total Recon, LLC · Jul 2017
K170482 · Spider Frame External Fixation System
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