Cleared Traditional

K143721 - PRCT2

K143721 is an FDA 510(k) clearance for PRCT2, manufactured by Fx Solutions. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K143721 · Fx Solutions · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
241d
Days
Class 2
Risk

K143721 is an FDA 510(k) clearance for the PRCT2. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Fx Solutions (Viriat, FR). The FDA issued a Cleared decision on August 27, 2015 after a review of 241 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.

FDA 510(k) Submission Details - K143721

510(k) Number K143721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date August 27, 2015
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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

Ferguson Medical International Device Consultants, LLC
FRANK FERGUSON

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 1312
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K143721.
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K151277 · Novastep · Aug 2015
Conventus PRS System
K151379 · Conventus Orthopaedics, Inc. · Aug 2015
RECON system
K151407 · Normed Medizin-Technik GmbH · Aug 2015