Cleared Traditional

K181843 - MLP Special Locking Bone Plate System

K181843 is the FDA 510(k) clearance for MLP Special Locking Bone Plate System by Maxxion Medical, LLC / Baumer SA. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K181843 · Maxxion Medical, LLC / Baumer SA · Orthopedic device
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Mar 2019
Decision
236d
Days
Class 2
Risk

K181843 is an FDA 510(k) clearance for the MLP Special Locking Bone Plate 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 Maxxion Medical, LLC / Baumer SA (Miami, US). The FDA issued a Cleared decision on March 4, 2019 after a review of 236 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 Maxxion Medical, LLC / Baumer SA devices

Submission Details

510(k) Number K181843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2018
Decision Date March 04, 2019
Days to Decision 236 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
114d slower than avg
Panel avg: 122d · This submission: 236d
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 Consultant

Medical Products International
Larry Petersen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

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