Cleared Traditional

K170056 - IRENE Cannulated Screw System

K170056 is the FDA 510(k) clearance for IRENE Cannulated Screw System by Tianjin Zhengtian Medical Instrument Co., Ltd.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K170056 · Tianjin Zhengtian Medical Instrument Co., Ltd. · Orthopedic device
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Oct 2017
Decision
290d
Days
Class 2
Risk

K170056 is an FDA 510(k) clearance for the IRENE Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tianjin Zhengtian Medical Instrument Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on October 23, 2017 after a review of 290 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Tianjin Zhengtian Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K170056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2017
Decision Date October 23, 2017
Days to Decision 290 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
168d slower than avg
Panel avg: 122d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 568
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170056.
HBS2 Headless Bone Screw
K171628 · Stuckenbrock Medizintechnik GmbH · Jan 2018
Cannulated Screw Internal Fixation System
K173286 · Life Spine, Inc. · Dec 2017
VariAx 2 System
K173135 · Stryker GmbH · Nov 2017
Large Screws Range
K172596 · Newclip Technics · Oct 2017
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017