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.

Core Shoulder System · Shoulder Arthroplasty Implantation System → Orthopedic

Name: Core Shoulder System
Brand: Core Shoulder System

1manufacturer

13catalogue 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 Core Shoulder System
Listed by	Link BIO Corp
FDA product code	QHE
Device type	Shoulder Arthroplasty Implantation System
Device class	Class 2
Regulation	21 CFR 888.3660
510(k)	K241470
Record published	2025-06-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for Core Shoulder System
Catalogue number	Size	Status
87-9133/20L		In distribution
87-9133/16R		In distribution
87-9131		In distribution
87-9133/24R		In distribution
87-9134		In distribution
87-9133/20R		In distribution
87-9133/28L		In distribution
87-9137		In distribution
87-9136		In distribution
87-9133/28R		In distribution
87-9132		In distribution
87-9133/16L		In distribution
87-9133/24L		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Smart Space Shoulder	Limacorporate	13
Blueprint	Tornier Inc.	5
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 510(k) it is cleared under.

Recalls naming the identifiers of Core Shoulder System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
LinkBio Corp.	510(k) number	2026-03-12	Class II	Under Investigation by firm	The CORE Workstation may display an incorrect “Planning Date ” when viewing cases on the “Start Case” menu screen.	5 units

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.

Core Shoulder System