Cleared Traditional

K170056 - IRENE Cannulated Screw System

K170056 is an FDA 510(k) clearance for IRENE Cannulated Screw System, manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K170056

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 942
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170056.
PIT’Stop® implant
K170688 · In2bones Sas · Nov 2017
VariAx 2 System
K173135 · Stryker GmbH · Nov 2017
Treace Medical Concepts (TMC) Compression Screw System
K172617 · Treace Medical Concepts, Inc. · Oct 2017
MECRON Cannulated Screw System
K172213 · Merete GmbH · Oct 2017
Large Screws Range
K172596 · Newclip Technics · Oct 2017
BePOD® Foot Screws
K163148 · Fournitures Hospitalieres Industrie · Sep 2017