Cleared Traditional

K221221 - Advanced Intramedullary Nail System

K221221 is an FDA 510(k) clearance for Advanced Intramedullary 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 238-day FDA review.

K221221 · Double Medical Technology, Inc. · Orthopedic device
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Dec 2022
Decision
238d
Days
Class 2
Risk

K221221 is an FDA 510(k) clearance for the Advanced Intramedullary 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 December 21, 2022 after a review of 238 days - an extended review cycle.

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 Double Medical Technology, Inc. devices

FDA 510(k) Submission Details - K221221

510(k) Number K221221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2022
Decision Date December 21, 2022
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K221221.
Precice Intramedullary Limb Lengthening System
K220234 · Nuvasive Specialized Orthopedics, Inc. · Mar 2023
Pro-X1™ Trochanteric Nailing System
K221621 · X-Bolt Orthopedics · Mar 2023
Dyna Locking Trochanteric Nail™
K221084 · Innosys · Mar 2023
Arthrex DualCompression Hindfoot Fusion Nail Implant System
K221031 · Arthrex, Inc. · Dec 2022
Femoral Trochanteric Nail System – Neonail
K221021 · Neoortho Produtos Ortop?dicos S/A · Dec 2022
Flex-Thread™ Ulna Intramedullary Nail System
K222390 · Flower Orthopedics Corporation Dba Conventus Flower · Nov 2022