Cleared Special

K110322 - OLECRA INTRAMEDULLARY FIXATION SYSTEM

K110322 is an FDA 510(k) clearance for OLECRA INTRAMEDULLARY FIXATION SYSTEM, manufactured by Mylad Orthopedic Solutions. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 29-day FDA review.

K110322 · Mylad Orthopedic Solutions · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
29d
Days
Class 2
Risk

K110322 is an FDA 510(k) clearance for the OLECRA INTRAMEDULLARY FIXATION SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Mylad Orthopedic Solutions (Mclean, US). The FDA issued a Cleared decision on March 4, 2011 after a review of 29 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.

FDA 510(k) Submission Details - K110322

510(k) Number K110322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2011
Decision Date March 04, 2011
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 515
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K110322.
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K110322 · OLECRA INTRAMEDULLARY FIXATION SYSTEM
Download PDF FDA Summary Mylad Orthopedic Solu…