What is FDA product code QHE?

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Blueprint · Shoulder Arthroplasty Implantation System → Orthopedic

Name: Blueprint
Brand: Blueprint

1manufacturer

5catalogue numbers in this listing

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code QHE
Manufacturer	City	Province	Registered as	Device types
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38

Record

Regulatory record for Blueprint
Listed by	Tornier Inc., United States
FDA product code	QHE
Device type	Shoulder Arthroplasty Implantation System
Device class	Class 2
Regulation	21 CFR 888.3660
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K232265
Record published	2023-02-13
Record revised	2024-10-07 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Blueprint
Catalogue number	Size	Status
BPUE001		In distribution
BPUE001		In distribution
BPUE001		In distribution
BPUE001		In distribution
BPUE001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Smart Space Shoulder	Limacorporate	13
Core Shoulder System	Link BIO Corp	13
SurgiCase Planner	Materialise NV	3
Signature ONE Software Package	Orthosoft, Inc.	3
Arthrex®	Arthrex, Inc.	3
Signature ONE	Orthosoft, Inc.	2
Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left	Orthosoft, Inc.	2
AtlasPlan	Materialise NV	2
Match Point System	Materialise NV	2
Comprehensive® Total Shoulder Guide and Bone Model Right	Orthosoft, Inc.	2
Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left	Orthosoft, Inc.	2
Shoulder Pure Planning	Orthosoft, Inc.	1

Showing 12 of 16. All products under Shoulder Arthroplasty Implantation System

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Blueprint
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason
Tornier S.A.S	UDI-DI	2024-04-16	Class II	Software change control	The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Blueprint