Class Class II
CORE Shoulder System (K241470)
Description
CORE Shoulder System by LinkBio Corp., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241470
Clearance Date2025-02-20
Clearance TypeTraditional
Product CodeQHE
Regulation Number888.3660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241470
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CORE Shoulder System (K241470) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2023 |
| K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | 2021 |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 |
| K170702 | mediCAD 4.0 | Medicad Hectec GmbH | 2018 |
| K123122 | GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) | Cleveland Clinic | 2013 |
Trace the full predicate network for K241470
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.