Cleared Traditional

Additive Orthopaedics Patient Specific 3D Printed Bone Segments (K180239) - FDA 510(k) Clearance

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

K180239 · Additive Orthopaedics, LLC · Orthopedic device
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May 2018
Decision
107d
Days
Class 2
Risk

K180239 is an FDA 510(k) clearance for the Additive Orthopaedics Patient Specific 3D Printed Bone Segments. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Additive Orthopaedics, LLC (Little Silver, US). The FDA issued a Cleared decision on May 16, 2018 after a review of 107 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 Additive Orthopaedics, LLC devices

Submission Details

510(k) Number K180239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date May 16, 2018
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K180239.
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IXOS Radius Plate System
K171624 · Stuckenbrock Medizintechnik GmbH · Mar 2018