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FDA 510(k)

BLUEPRINT™ Patient Specific Instrumentation

K-Number: K203315 · 2021-04-15

ApplicantTornier S.A.S.
Decision Date2021-04-15
Product CodeKWS
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 2021-04-15 under 510(k) 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. The listed applicant is Tornier S.A.S.. The 510(k) number is K203315.

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

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

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 KWS.

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.

K232265BLUEPRINT™ Patient Specific InstrumentationK222510Blueprint Mixed Reality systemK190521Aequalis Ascend Flex Shoulder SystemK162800BLUEPRINT Patient Specific InstrumentationK161789BLUEPRINT Patient Specific InstrumentationK153452Salto XT, Salto Talaris

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Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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