Cleared Traditional

K163323 - Dolphix® External Fixation System MR Conditional

K163323 is an FDA 510(k) clearance for Dolphix External Fixation System MR Con..., manufactured by Citieffe S.R.L.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K163323 · Citieffe S.R.L. · Orthopedic device
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Mar 2017
Decision
115d
Days
Class 2
Risk

K163323 is an FDA 510(k) clearance for the Dolphix® External Fixation System MR Conditional. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Citieffe S.R.L. (Calderara Di Reno, IT). The FDA issued a Cleared decision on March 20, 2017 after a review of 115 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 Citieffe S.R.L. devices

FDA 510(k) Submission Details - K163323

510(k) Number K163323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2016
Decision Date March 20, 2017
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 Consultant

Thelma S.R.L
Marisa Testa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 381
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K163323.
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