Cleared Traditional

K112389 - SURGICASE CONNECT, SURGICASE GUIDE

K112389 is an FDA 510(k) clearance for SURGICASE CONNECT, 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 337-day FDA review.

K112389 · Materialise NV · Orthopedic device
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Jul 2012
Decision
337d
Days
Class 2
Risk

K112389 is an FDA 510(k) clearance for the SURGICASE CONNECT, SURGICASE GUIDE. 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 July 20, 2012 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K112389

510(k) Number K112389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2011
Decision Date July 20, 2012
Days to Decision 337 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
215d slower than avg
Panel avg: 122d · This submission: 337d
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.