Cleared Traditional

K093533 - ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0

K093533 is an FDA 510(k) clearance for ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, manufactured by Materialise NV. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K093533 · Materialise NV · Orthopedic device
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Feb 2010
Decision
93d
Days
Class 2
Risk

K093533 is an FDA 510(k) clearance for the ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on February 17, 2010 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 - K093533

510(k) Number K093533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2009
Decision Date February 17, 2010
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 142
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K093533.
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