Cleared Traditional

K132290 - SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES

K132290 is an FDA 510(k) clearance for SURGICASE ORTHOPAEDICS SYSTEM, manufactured by Materialise NV. The device is a Class 2 Orthopedic device with product code PBF cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K132290 · Materialise NV · Orthopedic device
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Apr 2014
Decision
261d
Days
Class 2
Risk

K132290 is an FDA 510(k) clearance for the SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES. Classified as Orthopaedic Surgical Planning And Instrument Guides (product code PBF), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on April 10, 2014 after a review of 261 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 Materialise NV devices

FDA 510(k) Submission Details - K132290

510(k) Number K132290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2013
Decision Date April 10, 2014
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBF Device Classification - Class 2, Special Controls

Product Code PBF Orthopaedic Surgical Planning And Instrument Guides
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.
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 - PBF Orthopaedic Surgical Planning And Instrument Guides

All 26
Devices cleared under the same product code (PBF) and FDA review panel - the closest regulatory comparables to K132290.
KLS Martin Individual Patient Solutions (IPS) Planning System
K192979 · KLS-Martin L.P. · Mar 2020
VSP Orthopedics System
K190044 · 3D Systems, Inc. · Aug 2019
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
K163156 · Materialise NV · Jan 2017
SURGICASE CONNECT, SURGICASE GUIDE
K112389 · Materialise NV · Jul 2012