510(k) Report

FDA applicant

Joimax GmbH

Karlsruhe, DE7 decisions2005–20210 recalls

FDA records 7 decisions for Joimax GmbH (Karlsruhe, DE) from 2005 to 2021: 7 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No 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 Joimax GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2015: 12016: 12017: 12019: 12020: 12021: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Joimax GmbH’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • OLOOrthopedic Stereotaxic Instrument1decision
  • HRXArthroscope1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 168 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 1 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.

  • K051827Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys Laminoscope/MultiscopeJoimax GmbH · 20058cite it
  • K161378joimax Electrosurgical InstrumentsJoimax GmbH · 20161cites it
  • K151143EndoLIF On-CageJoimax GmbH · 20151cites it
  • K192663Joimax Intracs SystemJoimax GmbH · 20201cites it

What has FDA decided for it lately?

  • K203014EndoLIF Delta-Cage and DoubleWedge-CageJoimax GmbH · 2021
  • K192663Joimax Intracs SystemJoimax GmbH · 2020
  • K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH · 2019
  • K170358joimax Endovapor 2Joimax GmbH · 2017
  • K161378joimax Electrosurgical InstrumentsJoimax GmbH · 2016
  • K151143EndoLIF On-CageJoimax GmbH · 2015
  • K051827Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys Laminoscope/MultiscopeJoimax GmbH · 2005

All 7 as Joimax GmbH →