Cleared Traditional

K152548 - AXI+LINE Proximal Bunion Correction System

K152548 is an FDA 510(k) clearance for AXI+LINE Proximal Bunion Correction System, manufactured by Nextremity Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K152548 · Nextremity Solutions, Inc. · Orthopedic device
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Dec 2015
Decision
104d
Days
Class 2
Risk

K152548 is an FDA 510(k) clearance for the AXI+LINE Proximal Bunion Correction 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 December 21, 2015 after a review of 104 days - within the typical 510(k) review window.

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 Nextremity Solutions, Inc. devices

FDA 510(k) Submission Details - K152548

510(k) Number K152548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date December 21, 2015
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1006
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