FDA 510(k)

BLUEPRINT™ Patient Specific Instrumentation

K-Number: K232265 · 2024-02-21

Decision Date2024-02-21

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BLUEPRINT™ Patient Specific Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2024-02-21 under 510(k) number K232265. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUEPRINT™ Patient Specific Instrumentation?

BLUEPRINT™ Patient Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is Tornier S.A.S.. The 510(k) number is K232265.

When did BLUEPRINT™ Patient Specific Instrumentation receive FDA 510(k) clearance?

BLUEPRINT™ Patient Specific Instrumentation received FDA 510(k) clearance on 2024-02-21, under 510(k) number K232265.

Who is the listed applicant for BLUEPRINT™ Patient Specific Instrumentation?

The FDA 510(k) record lists Tornier S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUEPRINT™ Patient Specific Instrumentation?

The FDA product code for BLUEPRINT™ Patient Specific Instrumentation is PHX.

Other records listing Tornier S.A.S. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.