Cleared Traditional

K140027 - ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SY...

K140027 is the FDA 510(k) clearance for ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SY... by Materialise NV. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K140027 · Materialise NV · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
136d
Days
Class 2
Risk

K140027 is an FDA 510(k) clearance for the ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on May 22, 2014 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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

Submission Details

510(k) Number K140027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2014
Decision Date May 22, 2014
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 785
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K140027.
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K140833 · Conformis, Inc. · Jun 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555 · Smith & Nephew, Inc. · May 2014
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K140423 · Conformis, Inc. · May 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560 · Conformis, Inc. · Mar 2014
ULTRACONGRUENT INSERT
K132752 · United Orthopedic Corporation · Mar 2014
ARTHREX IBALANCE TKA SYSTEM
K133854 · Arthrex, Inc. · Feb 2014