Cleared Special

K152370 - PRECICE Trauma Nail System

K152370 is an FDA 510(k) clearance for PRECICE Trauma Nail System, manufactured by Ellipse Technologies, Incorporated. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 123-day FDA review.

K152370 · Ellipse Technologies, Incorporated · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
123d
Days
Class 2
Risk

K152370 is an FDA 510(k) clearance for the PRECICE Trauma Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Ellipse Technologies, Incorporated (Irvine, US). The FDA issued a Cleared decision on December 22, 2015 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K152370

510(k) Number K152370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2015
Decision Date December 22, 2015
Days to Decision 123 days
Submission Type Special
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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 511
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K152370.
PRECICE Trauma Nail System
K160267 · Ellipse Technologies, Incorporated · Mar 2016
Sonoma Fibula Repair System
K160069 · Sonoma Orthopedics Products, Inc. · Mar 2016
Piccolo Composite® Nailing System
K153536 · CarboFix Orthopedics , Ltd. · Jan 2016
WASTON Metallic Intramedullary Nail System
K151062 · Changzhou Waston Medical Appliance Co., Ltd. · Dec 2015
Cardinal Health Trochanteric IM Nail System
K150769 · Cardinalhealth · Dec 2015
SIGN Hip Construct (SHC)
K152757 · Sign Fracture Care International · Nov 2015