Cleared Traditional

K221181 - Treace Medical Concepts (TMC) Plating S...

K221181 is the FDA 510(k) clearance for Treace Medical Concepts (TMC) Plating S... by Treace Medical Concepts, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K221181 · Treace Medical Concepts, Inc. · Orthopedic device
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Jan 2023
Decision
255d
Days
Class 2
Risk

K221181 is an FDA 510(k) clearance for the Treace Medical Concepts (TMC) Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Treace Medical Concepts, Inc. (Ponte Vedra, US). The FDA issued a Cleared decision on January 5, 2023 after a review of 255 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K221181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date January 05, 2023
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K221181.
Medline UNITE® Ankle Fusion Plating System
K222665 · Medline Industries, Inc. · Jan 2023
OIC Variable Angle Small Fragment Locking Plate System
K223118 · Orthopaedic Implant Company · Jan 2023
Anatomic Bone Plate
K221088 · Double Medical Technology, Inc. · Jan 2023
TriMed Wrist Fixation System 3
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ARIX Rib System
K221412 · Jeil Medical Corporation · Nov 2022
ALPHALOK Plating System
K221558 · Vilex, LLC · Nov 2022