Cleared Traditional

K131677 - PRECICE INTRAMEDULLARY LIMB LENGTHENING...

K131677 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 Traditional 510(k) pathway after a 123-day FDA review.

K131677 · Ellipse Technologies, Inc. · Orthopedic device
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Oct 2013
Decision
123d
Days
Class 2
Risk

K131677 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 October 11, 2013 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. 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.

View all Ellipse Technologies, Inc. devices

FDA 510(k) Submission Details - K131677

510(k) Number K131677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2013
Decision Date October 11, 2013
Days to Decision 123 days
Submission Type Traditional
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
Predicate-based equivalence. No clinical trials required.

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 K131677.
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