Cleared Traditional

K143374 - BLUEPRINT Patient Specific Instrumentation

K143374 is an FDA 510(k) clearance for BLUEPRINT Patient Specific Instrumentation, manufactured by Tornier S.A.S.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K143374 · Tornier S.A.S. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
134d
Days
Class 2
Risk

K143374 is an FDA 510(k) clearance for the BLUEPRINT Patient Specific Instrumentation. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier S.A.S. (Montbonnot-Saint-Martin, FR). The FDA issued a Cleared decision on April 8, 2015 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 Tornier S.A.S. devices

FDA 510(k) Submission Details - K143374

510(k) Number K143374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2014
Decision Date April 08, 2015
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 183
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K143374.
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
K151293 · Tornier S.A.S. · Sep 2015
SMR Modular Glenoid
K143256 · Lima Corporate S.P.A. · May 2015
Aequalis PerFORM+ Shoulder System
K150583 · Tornier, Inc. · Apr 2015
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K142072 · Custom Orthopaedic Solutions, Inc. · Nov 2014
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
K142403 · Zimmer GmbH · Nov 2014
TITAN Modular Total Shoulder System
K142413 · Ascension Orthopedics · Nov 2014