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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 a medical device manufactured by Stryker Corporation (Tornier, S.A.S.). It received FDA 510(k) clearance on 2026-04-03 under approval 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. It is manufactured by Stryker Corporation (Tornier, S.A.S.). The 510(k) number is K253674.

When was Blueprint Patient-Specific Instrumentation approved by the FDA?

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

What company makes Blueprint Patient-Specific Instrumentation?

Blueprint Patient-Specific Instrumentation is manufactured by Stryker Corporation (Tornier, S.A.S.).

What is the FDA product code for Blueprint Patient-Specific Instrumentation?

The FDA product code for Blueprint Patient-Specific Instrumentation is PHX.

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026)

Other Devices by Stryker Corporation (Tornier, S.A.S.)

K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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.

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