Cleared Traditional

K203315 - BLUEPRINT Patient Specific Instrumentation

K203315 is the FDA 510(k) clearance for BLUEPRINT Patient Specific Instrumentation by Tornier S.A.S.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K203315 · Tornier S.A.S. · Orthopedic device
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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

Submission Details

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.

Device Classification

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 152
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K203315.
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K202289 · Stryker GmbH · Dec 2020