Cleared Traditional

Double Medical Femoral Nail System (K172830) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 262
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