Cleared Special

K103533 - ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM

K103533 is an FDA 510(k) clearance for ES TROCHANTERIC NAIL, manufactured by Advanced Orthopaedic Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 49-day FDA review.

K103533 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
49d
Days
Class 2
Risk

K103533 is an FDA 510(k) clearance for the ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on January 19, 2011 after a review of 49 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 - K103533

510(k) Number K103533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2010
Decision Date January 19, 2011
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 529
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K103533.
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K110322 · Mylad Orthopedic Solutions · Mar 2011
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PICCOLO COMPOSITE NAILING SYSTEM
K102369 · N.M.B. Medical Applications, Ltd. · Jan 2011
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
K102992 · Howmedica Osteonics Corp. · Dec 2010
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
K101939 · Merete Medical GmbH · Oct 2010
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
K101622 · Zimmer, Inc. · Oct 2010
K103533 · ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
Download PDF FDA Summary Advanced Orthopaedic …