Cleared Traditional

K150780 - Acetabular Cup Orientation System (FDA 510(k) Clearance)

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

K150780 · Materialise NV · Orthopedic device
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Oct 2015
Decision
216d
Days
Class 2
Risk

K150780 is an FDA 510(k) clearance for the Acetabular Cup Orientation System. Classified as Acetabular Cup Orientation System (product code PLW), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on October 27, 2015 after a review of 216 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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.

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Submission Details

510(k) Number K150780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2015
Decision Date October 27, 2015
Days to Decision 216 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
94d slower than avg
Panel avg: 122d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLW Acetabular Cup Orientation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
Definition The Acetabular Cup Orientation System Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Orientation Of Acetabular Cup Components Used With Total Hip Arthroplasty. The Device Utilizes Anatomic Landmarks Of The Pelvis That Are Clearly Identifiable On Pre-operative Imaging Scans.
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.