510(k) Report

FDA applicant

Kelyniam Global, Inc.

Canton, CT4 decisions2011–20254 recalls

FDA records 4 decisions for Kelyniam Global, Inc. (Canton, CT) from 2011 to 2025: 4 510(k) clearances. Most are in product codes GWO (Plate, Cranioplasty, Preformed, Alterable) and GXN (Plate, Cranioplasty, Preformed, Non-Alterable). Its devices cite 14 predicates, 6 of them its own earlier devices. 4 recalls are linked to its devices.

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

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

How often FDA has decided Kelyniam Global, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 12012: 12019: 12025: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

4in 2017

2017: 4
2011high 4 (2017) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Kelyniam Global, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kelyniam Global, Inc.’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?

  • GWOPlate, Cranioplasty, Preformed, Alterable2decisions
  • GXNPlate, Cranioplasty, Preformed, Non-Alterable2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 20114cite it
  • K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 20193cite it
  • K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 20122cite it

What has FDA decided for it lately?

  • K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc. · 2025
  • K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
  • K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
  • K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 20114 recalls

All 4 as Kelyniam Global, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K103582Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003Jun 10, 2017Class II
  • K103582Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002Jun 10, 2017Class II
  • K103582Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004Jun 10, 2017Class II
  • K103582Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)Jun 10, 2017Class II