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)
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.

View all Ellipse Technologies, Incorporated devices

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
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 380
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K152370.
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016
DePuy Synthes TFNA Augmentation System
K160167 · Synthes USA Products, LLC · Sep 2016
Piccolo Composite® Nailing System
K153536 · CarboFix Orthopedics , Ltd. · Jan 2016
Cardinal Health Trochanteric IM Nail System
K150769 · Cardinalhealth · Dec 2015
Piccolo Composite Nailing System
K151010 · CarboFix Orthopedics , Ltd. · Jul 2015
Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015