Cleared Special

K133289 - PRECICE INTRAMEDULLARY LIMB LENGTHENING...

K133289 is an FDA 510(k) clearance for PRECICE INTRAMEDULLARY LIMB LENGTHENING..., manufactured by Ellipse Technologies, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 45-day FDA review.

K133289 · Ellipse Technologies, Inc. · Orthopedic device
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Dec 2013
Decision
45d
Days
Class 2
Risk

K133289 is an FDA 510(k) clearance for the PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Ellipse Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on December 9, 2013 after a review of 45 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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, Inc. devices

FDA 510(k) Submission Details - K133289

510(k) Number K133289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date December 09, 2013
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 K133289.
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