Cleared Special

K160555 - BLUEPRINT Patient Specific Instrumentation

K160555 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 Special 510(k) pathway after a 102-day FDA review.

K160555 · Tornier S.A.S. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
102d
Days
Class 2
Risk

K160555 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 June 10, 2016 after a review of 102 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K160555

510(k) Number K160555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date June 10, 2016
Days to Decision 102 days
Submission Type Special
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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Modification to existing cleared device.

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 191
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K160555.
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
K161863 · Stryker GmbH · Nov 2016
AltiVate Anatomic Shoulder System
K162024 · Encore Medical, L.P. · Nov 2016
Arthrex VaultLock Glenoid
K161108 · Arthrex, Inc. · Aug 2016
Aequalis PerFORM+ Shoulder System
K160975 · Tornier, Inc. · Jun 2016
Materialise Glenoid Positioning System
K153602 · Materialise NV · Apr 2016
SMR 3-Pegs Glenoids
K153722 · Lima Corporate S.P.A. · Apr 2016
K160555 · BLUEPRINT Patient Specific Instrumentation
Download PDF FDA Summary Tornier S.A.S.