Cleared Traditional

JACE Medical Thoracic Plating System (K210290) - FDA 510(k) Clearance

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

K210290 · Jace Medical, LLC · Orthopedic device
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Apr 2021
Decision
87d
Days
Class 2
Risk

K210290 is an FDA 510(k) clearance for the JACE Medical Thoracic 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 Jace Medical, LLC (Warsaw, US). The FDA issued a Cleared decision on April 30, 2021 after a review of 87 days - a notably fast clearance 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: 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 Jace Medical, LLC devices

Submission Details

510(k) Number K210290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2021
Decision Date April 30, 2021
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 Consultant

MRC Global
Dawn N. 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 - HRS Plate, Fixation, Bone

All 699
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K210290.
Valkyrie Thoracic Fixation System
K211695 · Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · Jun 2021
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
K211051 · DePuy Synthes · Jun 2021
DRPx Locking Distal Radius Plate System
K202971 · Orthopaedic Implant Company · May 2021
SOLE Medial Column Fusion Plate
K210157 · Orthofix Srl · Apr 2021
Volition Plating System
K210658 · Ortho Solutions UK , Ltd. · Apr 2021
DePuy Synthes Variable Angle Locking Patella Plating System
K210408 · Synthes USA Products, LLC · Apr 2021