Cleared Traditional

K103002 - SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM

K103002 is an FDA 510(k) clearance for SYNTHES MULTILOC PROXIMAL HUMERAL NAILI..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K103002 · Synthes (Usa) · Orthopedic device
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Mar 2011
Decision
145d
Days
Class 2
Risk

K103002 is an FDA 510(k) clearance for the SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 2, 2011 after a review of 145 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K103002

510(k) Number K103002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2010
Decision Date March 02, 2011
Days to Decision 145 days
Submission Type Traditional
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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K103002.
PICCOLO COMPOSITE NAILING SYSTEM
K111056 · CarboFix Orthopedics , Ltd. · May 2011
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
K110552 · Wrightmedicaltechnologyinc · Mar 2011
OLECRA INTRAMEDULLARY FIXATION SYSTEM
K110322 · Mylad Orthopedic Solutions · Mar 2011
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
K103533 · Advanced Orthopaedic Solutions, Inc. · 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