Cleared Traditional

DIP Arthrodesis System (K173616) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173616 · In2bones Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
58d
Days
Class 2
Risk

K173616 is an FDA 510(k) clearance for the DIP Arthrodesis System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on January 19, 2018 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all In2bones Sas devices

Submission Details

510(k) Number K173616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2017
Decision Date January 19, 2018
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
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

Mrc-X, LLC
Christine Scifert

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 - HTY Pin, Fixation, Smooth

All 70
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K173616.
A.M. Surgical Intramedullary Fixation Device
K180087 · A.M. Surgical, Inc. · May 2018
HammerTube System
K171715 · Paragon 28 · Mar 2018
Footmotion HammerToe
K172485 · Newclip Technics · Mar 2018
dynaMX Intramedullary Implant
K170326 · Arthrex, Inc. · Jul 2017
Rush Medullary Pins
K150626 · Zimmer, Inc. · May 2015
Arthrex Blunt Tip Screws with Fiber Tape
K143702 · Arthrex, Inc. · Apr 2015