Cleared Traditional

K172830 - Double Medical Femoral Nail System

K172830 is an FDA 510(k) clearance for Double Medical Femoral Nail System, manufactured by Double Medical Technology, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K172830 · Double Medical Technology, Inc. · Orthopedic device
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Aug 2018
Decision
340d
Days
Class 2
Risk

K172830 is an FDA 510(k) clearance for the Double Medical Femoral Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on August 24, 2018 after a review of 340 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 Double Medical Technology, Inc. devices

FDA 510(k) Submission Details - K172830

510(k) Number K172830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date August 24, 2018
Days to Decision 340 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
218d slower than avg
Panel avg: 122d · This submission: 340d
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 378
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K172830.
Panta 2 Arthrodesis Nail System
K181639 · Integra LifeSciences Corporation · Nov 2018
OsteoBridge™ IDSF System
K181026 · Merete GmbH · Oct 2018
X-BOLT Hip Fracture Fixation System
K181640 · X-Bolt Orthopaedics · Oct 2018
OIC Intramedullary Nail System
K181184 · The Orthopaedic Implant Company · Jul 2018
Arthrex FibuLock Nail
K173656 · Arthrex, Inc. · Jul 2018
Apex Femoral Nailing System
K181375 · Orthoxel · Jul 2018