Cleared Traditional

Clavicle and Scapula System (K240181) - FDA 510(k) Clearance

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

K240181 · Auxein Medical Pvt., Ltd. · Orthopedic device
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Oct 2024
Decision
260d
Days
Class 2
Risk

K240181 is an FDA 510(k) clearance for the Clavicle and Scapula System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Auxein Medical Pvt., Ltd. (Sonepat, IN). The FDA issued a Cleared decision on October 9, 2024 after a review of 260 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Auxein Medical Pvt., Ltd. devices

Submission Details

510(k) Number K240181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2024
Decision Date October 09, 2024
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 698
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K240181.
Bonebridge Osteosynthesis Plating System
K242399 · Bonebridge AG · Oct 2024
OIC Small / Mini Fragment Plate System
K242995 · The Orthopaedic Implant Company · Oct 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
K242554 · Arthrex, Inc. · Oct 2024
Pangea Platform
K242445 · Stryker GmbH · Oct 2024
BPS Wrist Fracture System
K242343 · Orthonovis, Inc. · Oct 2024
Protean Fragment Plating System
K241815 · Skeletal Dynamics, Inc. · Sep 2024