Cleared Traditional

K183363 - Treace Medical Concepts (TMC) Snap-Off ...

K183363 is the FDA 510(k) clearance for Treace Medical Concepts (TMC) Snap-Off ... by Treace Medical Concepts, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K183363 · Treace Medical Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
191d
Days
Class 2
Risk

K183363 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Snap-Off Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Treace Medical Concepts, Inc. (Ponte Vedra, US). The FDA issued a Cleared decision on June 13, 2019 after a review of 191 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 Treace Medical Concepts, Inc. devices

Submission Details

510(k) Number K183363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2018
Decision Date June 13, 2019
Days to Decision 191 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
69d slower than avg
Panel avg: 122d · This submission: 191d
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 Consultant

Mrc-X, LLC
Dawn Norman

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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K183363.
Bone Screw Line Addition
K191289 · Vilex IN Tennessee, Inc. · Jul 2019
ActivOrtho Continuous Compression Screw System
K191817 · Activortho, Inc. · Jul 2019
OrthoPediatrics Cannulated Screw System
K190324 · OrthoPediatrics Corp. · Jul 2019
Mini Cannulated Headed and Headless Screw Set
K183104 · Stryker GmbH · Jun 2019
InCore® Lapidus Sterile Kits
K190231 · Nextremity Solutions, Inc. · May 2019
IntraLock Lapidus System
K182342 · Fusion Orthopedics, LLC · May 2019