Cleared Traditional

K101997 - ELLIPSE INTRAMEDULLARY LIMB LENGTHENING...

K101997 is an FDA 510(k) clearance for ELLIPSE 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 362-day FDA review.

K101997 · Ellipse Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2011
Decision
362d
Days
Class 2
Risk

K101997 is an FDA 510(k) clearance for the ELLIPSE 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 July 12, 2011 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K101997

510(k) Number K101997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2010
Decision Date July 12, 2011
Days to Decision 362 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
240d slower than avg
Panel avg: 122d · This submission: 362d
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
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