Cleared Traditional

K203315 - BLUEPRINT™ Patient Specific Instrumentation

K203315 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 156-day FDA review.

K203315 · Tornier S.A.S. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
156d
Days
Class 2
Risk

K203315 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 15, 2021 after a review of 156 days - an extended review cycle.

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 - K203315

510(k) Number K203315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2020
Decision Date April 15, 2021
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
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 K203315.
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K210861 · Stryker GmbH · Sep 2021
Augmented VaultLock Glenoid
K210050 · Arthrex, Inc. · Jun 2021
Global Shoulder and Delta CTA systems
K203230 · Depuy Lnc. · Apr 2021
AltiVate® Anatomic Pegged Glenoid with Markers
K203026 · Encore Medical, L.P. · Dec 2020
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K202289 · Stryker GmbH · Dec 2020