FDA 510(k)

BLUEPRINT Patient Specific Instrumentation

K-Number: K203315 · 2021-04-15

Decision Date2021-04-15

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BLUEPRINT Patient Specific Instrumentation is a medical device manufactured by Tornier S.A.S.. It received FDA 510(k) clearance on 2021-04-15 under approval number K203315. The device is classified under product code KWS. 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 2021-04-15. It is manufactured by Tornier S.A.S.. The 510(k) number is K203315.

When was BLUEPRINT Patient Specific Instrumentation approved by the FDA?

BLUEPRINT Patient Specific Instrumentation received FDA 510(k) clearance on 2021-04-15, under approval number K203315.

What company makes BLUEPRINT Patient Specific Instrumentation?

BLUEPRINT Patient Specific Instrumentation is manufactured by 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 KWS.

Related Clinical Trials

NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT06744036 Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis RECRUITING

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 Tornier S.A.S.

K161789BLUEPRINT Patient Specific Instrumentation K153452Salto XT, Salto Talaris K160555BLUEPRINT Patient Specific Instrumentation K152966Aequalis Fx2 K162800BLUEPRINT Patient Specific Instrumentation K190521Aequalis Ascend Flex Shoulder System

View all 10 devices →

Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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.