Cleared Traditional

K172617 - Treace Medical Concepts (TMC) Compression Screw System (FDA 510(k) Clearance)

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

K172617 · Treace Medical Concepts, Inc. · Orthopedic device
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Oct 2017
Decision
55d
Days
Class 2
Risk

K172617 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Compression Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Treace Medical Concepts, Inc. (Ponte Vedra Beach, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 55 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 Treace Medical Concepts, Inc. devices

Submission Details

510(k) Number K172617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2017
Decision Date October 25, 2017
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 1054
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K172617.
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Treace Medical Concepts (TMC) Screw Fixation System
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