Cleared Traditional

Humerus & Ulna System (K213108) - FDA 510(k) Clearance

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

K213108 · Auxein Medical Private Limited · Orthopedic device
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Nov 2022
Decision
406d
Days
Class 2
Risk

K213108 is an FDA 510(k) clearance for the Humerus & Ulna 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 Private Limited (Sonipat, IN). The FDA issued a Cleared decision on November 4, 2022 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Auxein Medical Private Limited devices

Submission Details

510(k) Number K213108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date November 04, 2022
Days to Decision 406 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
284d slower than avg
Panel avg: 122d · This submission: 406d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K213108.
TriMed Wrist Fixation System 3
K222637 · TriMed, Inc. · Dec 2022
ARIX Rib System
K221412 · Jeil Medical Corporation · Nov 2022
ALPHALOK Plating System
K221558 · Vilex, LLC · Nov 2022
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
K222282 · Hospital Equipment Manufacturing Company · Oct 2022
EVOS Wrist Spanning Plate
K213123 · Smith & Nephew, Inc. · Oct 2022
Varixis Elbow System
K213014 · Auxein Medical Private Limited · Oct 2022