# K241470: CORE Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: LinkBio Corp.
- Decided: Feb 20, 2025 after 272 days
- Product code: QHE (Shoulder Arthroplasty Implantation System)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K905070 (1991). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123122: Glenoid Intelligent Reusable Instrument System (Glenoid Iris), Cleveland Clinic (2013) Summary page 5.
- K222007: Arthrex Virtual Implant Positioning (VIP) System, Arthrex, Inc. (2023) Summary page 5.

## Recalls of this device
- Mar 12, 2026 · Class II · Z-1810-2026: The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

## Indications for use
The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy. The CORE Shoulder System is designed for use with the following LINK Implant systems: • LINK Embrace Shoulder System – Reverse Configuration (K200368, K212992, K231445) • LINK Embrace Shoulder System – Anatomic Configuration (K210899)

Source page: https://510kreport.com/device/K241470
Methodology: https://510kreport.com/methodology