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CORE Shoulder System

by LinkBio Corp.

510(k) K241470

CORE Shoulder System is a Class II device made by LinkBio Corp., cleared under FDA 510(k) K241470 on 20 Feb 2025, active as of 11 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241470 Date20 Feb 2025ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1810-2026 FDA Class II initiated 12 Mar 2026

    The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

Timeline

2 dated events

  1. Cleared FDA 510(k) K241470
  2. Recall initiated FDA recalls Z-1810-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QHE
Device class
Class II
Regulation
21 CFR Part 888.3660
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K241470

13 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K241470
UDI-DISize and differences
CORE Shoulder System 87-9131
LinkBio Corp.
87-913100810022403051
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9132
LinkBio Corp.
87-913200810022403068
Prescription: yes; Single use: yes
On the market
CORE Shoulder System 87-9133/16L
LinkBio Corp.
87-9133/16L00810022403129
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9133/16R
LinkBio Corp.
87-9133/16R00810022403167
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9133/20L
LinkBio Corp.
87-9133/20L00810022403136
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9133/20R
LinkBio Corp.
87-9133/20R00810022403174
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9133/24L
LinkBio Corp.
87-9133/24L00810022403143
Prescription: no; Single use: no
On the market
CORE Shoulder System 87-9133/24R
LinkBio Corp.
87-9133/24R00810022403181
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9133/28L
LinkBio Corp.
87-9133/28L00810022403150
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9133/28R
LinkBio Corp.
87-9133/28R00810022403198
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9134
LinkBio Corp.
87-913400810022403204
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9136
LinkBio Corp.
87-913600810022403099
Prescription: yes; Single use: no
On the market
CORE Shoulder System 87-9137
LinkBio Corp.
87-913700810022403105
Prescription: yes; Single use: no
On the market

Similar devices

Other devices filed under FDA product code QHE (Shoulder Arthroplasty Implantation System).

Other devices from LinkBio Corp.

See all devices from LinkBio Corp. →