510(k) Report

FDA applicant

LinkBio Corp.

Dover, NJ2 decisions2019–20251 recall

FDA records 2 decisions for LinkBio Corp. (Dover, NJ) from 2019 to 2025: 2 510(k) clearances. Most are in product codes QHE (Shoulder Arthroplasty Implantation System) and KRO (Prosthesis, Knee, Femorotibial, Constrained…). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided LinkBio Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12025: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2019high 1 (2026) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — LinkBio Corp. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like LinkBio Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QHEShoulder Arthroplasty Implantation System1decision
  • KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K241470CORE Shoulder SystemLinkBio Corp. · 20251 recall
  • K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. · 2019

All 2 as LinkBio Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K241470LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.Mar 12, 2026Class II