510(k) Report

FDA applicant

Medtech S.A

Montpellier, FR8 decisions2009–202021 recalls

FDA records 8 decisions for Medtech S.A (Montpellier, FR) from 2009 to 2020: 8 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 5 of them its own earlier devices. 21 recalls are linked to its devices, 2 Class I.

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 Medtech S.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 12015: 12016: 12018: 12019: 32020: 1
2009high 3 (2019) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2021

2012: 12013: 32014: 42015: 12016: 42017: 42019: 1, 1 Class I2020: 22021: 1, 1 Class I
2009high 4 (2014) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Medtech S.A by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtech S.A’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?

  • HAWNeurological Stereotaxic Instrument5decisions
  • OLOOrthopedic Stereotaxic Instrument3decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 160 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 5 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.

  • K151511ROSA SpineMedtech S.A · 20164cite it
  • K200511ROSA ONE Brain applicationMedtech S.A · 20203cite it
  • K182417ROSA ONE Brain ApplicationMedtech S.A · 20193cite it
  • K182848ROSA ONE Spine applicationMedtech S.A · 20193cite it
  • K151359ROSA BrainMedtech S.A · 20152cite it
  • K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 20091cites it

What has FDA decided for it lately?

  • K200511ROSA ONE Brain applicationMedtech S.A · 20201 Class I recall
  • K192173ROSA ONE Spine applicationMedtech S.A · 2019
  • K182848ROSA ONE Spine applicationMedtech S.A · 2019
  • K182417ROSA ONE Brain ApplicationMedtech S.A · 20191 Class I recall
  • K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 20181 Class I recall
  • K151511ROSA SpineMedtech S.A · 20163 recalls
  • K151359ROSA BrainMedtech S.A · 20151 Class I recall
  • K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 20099 recalls

All 8 as Medtech S.A →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K182417ROSA One 3.1 Brain application The device is intended for the spatial positioning and…Sep 22, 2021Class I
  • K172444ROSA One 3.1 Brain ApplicationJan 6, 2020Class II
  • K172444ROSA Brain 3.0 Application-BrainJan 6, 2020Class II
  • K151359Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case…Sep 10, 2019Class I
  • K172444ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for…May 1, 2017Class II
  • K151511ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for…May 1, 2017Class II

Other applicant names beginning “Medtech”

FDA records each applicant name separately; these may or may not be the same firm.

Medtech Products, Inc. 14Medtech Intl., Inc. 6Medtech S.A.S 4Medtech Industries, Inc. 4The Medtech Group, Inc. 2Medtech Instruments 2Medtech Systems, Inc. 1