Cleared Traditional

K140397 - PARALOCK PLATING SYSTEM / TUFFNEK SCREW

K140397 is an FDA 510(k) clearance for PARALOCK PLATING SYSTEM / TUFFNEK SCREW, manufactured by Paragon 28. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K140397 · Paragon 28 · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
58d
Days
Class 2
Risk

K140397 is an FDA 510(k) clearance for the PARALOCK PLATING SYSTEM / TUFFNEK SCREW. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Paragon 28 (Chesterland, US). The FDA issued a Cleared decision on April 17, 2014 after a review of 58 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 Paragon 28 devices

FDA 510(k) Submission Details - K140397

510(k) Number K140397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date April 17, 2014
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 Peers - HRS Plate, Fixation, Bone

All 1236
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140397.
MATRIXRIB FIXATION SYSTEM
K133616 · Synthes USA Products, LLC · May 2014
ORTHOPEDIC FIXATION SYSTEMS
K140216 · Impact Medical, LLC · May 2014
PINIT SMALL BONE FUSION SYSTEM
K140617 · Arthrosurface, Inc. · Apr 2014
VARIAX 2 SYSTEM
K140769 · Stryker Trauma AG · Apr 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
K140069 · Merete Medical GmbH · Apr 2014
FRAGMENT PLATE SYSTEM
K140372 · Skeletal Dynamics, LLC · Apr 2014