510(k) Report

FDA applicant

Medical Designs, LLC

Sioux Falls, SD7 decisions2000–20181 recall

FDA records 7 decisions for Medical Designs, LLC (Sioux Falls, SD) from 2000 to 2018: 7 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and JXG (Shunt, Central Nervous System And Components). Its devices cite 18 predicates, 4 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 Medical Designs, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2009: 12012: 12015: 12018: 2
2007high 2 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Designs, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medical Designs, LLC’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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • JXGShunt, Central Nervous System And Components2decisions
  • PEKSpinous Process Plate1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Whose devices does it build on?

Its devices cite 18 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 4 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.

  • K090048Asfora Bullet Cage SystemMedical Designs, LLC · 20094cite it
  • K112648Asfora Bullet CageMedical Designs, LLC · 20123cite it
  • K042359Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA…Medical Designs, LLC · 20042cite it
  • K002970Subdural Evacuating Port System, Model 11-9901Medical Designs, LLC · 20001cites it

What has FDA decided for it lately?

  • K182352SP-LINK™ SystemMedical Designs, LLC · 2018
  • K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC · 2018
  • K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC · 2015
  • K112648Asfora Bullet CageMedical Designs, LLC · 2012
  • K090048Asfora Bullet Cage SystemMedical Designs, LLC · 2009
  • K042359Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA…Medical Designs, LLC · 20041 recall
  • K002970Subdural Evacuating Port System, Model 11-9901Medical Designs, LLC · 2000

All 7 as Medical Designs, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042359Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits…Nov 26, 2013Class II