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Blueprint™ Patient Specific Instrumentation

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Model / Reference
MWJ003 FDA UDI

Identifiers

Primary DI / UDI-DI
03700386955648 FDA UDI
510(k) Number
K160555 FDA UDI
K161789 FDA UDI
FDA Product Code
KWS FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Blueprint™ Patient Specific Instrumentation by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Cleared under the same submission

K161789 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI debcabd2-a4c1-4d58-b805-dbb86b7b22a0 34 fields · synced May 30, 2026