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FDA 510(k)

BLUEPRINT Patient Specific Instrumentation

K-Number: K161789 · 2016-12-27

ApplicantTornier S.A.S.
Decision Date2016-12-27
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 2016-12-27 under 510(k) number K161789. 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 2016-12-27. The listed applicant is Tornier S.A.S.. The 510(k) number is K161789.

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

BLUEPRINT Patient Specific Instrumentation received FDA 510(k) clearance on 2016-12-27, under 510(k) number K161789.

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 systemK203315BLUEPRINT™ Patient Specific InstrumentationK190521Aequalis Ascend Flex Shoulder SystemK162800BLUEPRINT 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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