Cleared Traditional

K160174 - I.B.S. 2.0 Osteosynthesis screw

K160174 is an FDA 510(k) clearance for I.B.S. 2.0 Osteosynthesis screw, manufactured by In2bones Sas. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K160174 · In2bones Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
253d
Days
Class 2
Risk

K160174 is an FDA 510(k) clearance for the I.B.S. 2.0 Osteosynthesis screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on October 6, 2016 after a review of 253 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 In2bones Sas devices

FDA 510(k) Submission Details - K160174

510(k) Number K160174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date October 06, 2016
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
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 Consultant

Estrin Consulting Group,Llc
Norman F Estrin

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 - HWC Screw, Fixation, Bone

All 1019
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160174.
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AmorChem Titanium Porous Fixation Device
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HammerTech Fixation System
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The Hammertoe Correction System
K153065 · Life Spine, Inc. · Aug 2016
Cannulated Screw
K161058 · Miami Device Solutions, LLC · Jul 2016
Arthrosurface Bone Screws
K161539 · Arthrosurface, Inc. · Jun 2016