FDA 510(k)

Blueprint Patient-Specific Instrumentation

K-Number: K253674 · 2026-04-03

ApplicantStryker Corporation (Tornier, S.A.S.)

Decision Date2026-04-03

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 Stryker Corporation (Tornier, S.A.S.). It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K253674. 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 2026-04-03. The listed applicant is Stryker Corporation (Tornier, S.A.S.). The 510(k) number is K253674.

When did Blueprint Patient-Specific Instrumentation receive FDA 510(k) clearance?

Blueprint Patient-Specific Instrumentation received FDA 510(k) clearance on 2026-04-03, under 510(k) number K253674.

Who is the listed applicant for Blueprint Patient-Specific Instrumentation?

The FDA 510(k) record lists Stryker Corporation (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 Stryker Corporation (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.

K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

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.