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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 512
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K131609.
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
K141228 · Advanced Orthopaedic Solutions, Inc. · Jul 2014
FLOW-NAIL
K140601 · Flow-Fx, LLC · Jul 2014
PRECICE TRAUMA NAIL SYSTEM
K141447 · Ellipse Technologies, Inc. · Jun 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K141023 · Ellipse Technologies, Inc. · May 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · Synthes (Usa) · Mar 2014
METALLIC INTRAMEDULLARY NAIL SYSTEM
K132078 · Tianjin Walkman Biomaterial Co., Ltd. · Mar 2014
K131609 · DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
Download PDF FDA Summary Xiamen Double Engine …