Cleared Traditional

K131609 - DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM

K131609 is an FDA 510(k) clearance for DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM, manufactured by Xiamen Double Engine Medical Material Co., Ltd.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K131609 · Xiamen Double Engine Medical Material Co., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2014
Decision
352d
Days
Class 2
Risk

K131609 is an FDA 510(k) clearance for the DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Xiamen Double Engine Medical Material Co., Ltd. (Xiamen, Fujian, CN). The FDA issued a Cleared decision on May 21, 2014 after a review of 352 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 Xiamen Double Engine Medical Material Co., Ltd. devices

FDA 510(k) Submission Details - K131609

510(k) Number K131609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date May 21, 2014
Days to Decision 352 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
230d slower than avg
Panel avg: 122d · This submission: 352d
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 381
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K131609.
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K131984 · Synthes (Usa) · Mar 2014
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
K131548 · Synthes USA Products, LLC · Feb 2014
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
K133081 · Advanced Orthopaedic Solutions, Inc. · Dec 2013