Cleared Special

I.B.S. osteosynthesis screws (K170594) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170594 · In2bones Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
71d
Days
Class 2
Risk

K170594 is an FDA 510(k) clearance for the I.B.S. osteosynthesis screws. 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 May 10, 2017 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all In2bones Sas devices

Submission Details

510(k) Number K170594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2017
Decision Date May 10, 2017
Days to Decision 71 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 418
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170594.
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017
2-Piece Hammertoe Correction System
K162685 · Life Spine, Inc. · Jun 2017
Arthrex Compression Screws
K170382 · Arthrex, Inc. · May 2017
CAPTIVATE™ Compression Screws
K162825 · Globus Medical, Inc. · May 2017
HV Screw System
K170889 · Wrightmedicaltechnologyinc · Apr 2017
MICATM Screw System
K162353 · Wrightmedicaltechnologyinc · Apr 2017