Cleared Traditional

Stratum® Ankle Fusion Plating System (K212640) - FDA 510(k) Clearance

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

K212640 · Nextremity Solutions, Inc. · General Hospital
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Nov 2021
Decision
90d
Days
Class 2
Risk

K212640 is an FDA 510(k) clearance for the Stratum® Ankle Fusion Plating 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 Nextremity Solutions, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 18, 2021 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 888.3030 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Nextremity Solutions, Inc. devices

Submission Details

510(k) Number K212640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2021
Decision Date November 18, 2021
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 General Hospital 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 K212640.
The Radian MIS Bunion System
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Xpert Wrist
K213214 · Newclip Technics · Nov 2021
CoLink Vallux Plating System
K212487 · In2bones USA, LLC · Nov 2021
LOQTEQ Proximal Humerus Plate 3.5 System
K211582 · Aap Implantate AG · Oct 2021
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
K203002 · Bonebridge AG · Oct 2021
Anthem Fracture System
K212433 · Globus Medical, Inc. · Oct 2021