510(k) Report

FDA applicant

Clariance, Sas

Beaurains, FR22 decisions2012–20252 recalls

FDA records 22 decisions for Clariance, Sas (Beaurains, FR) from 2012 to 2025: 22 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 65 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 26 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Clariance”, “Clariance, SA”.

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 Clariance, Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12013: 22016: 22017: 32019: 32020: 12021: 42022: 12024: 42025: 1
2012high 4 (2021) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2026

2019: 12026 (partial year): 1
2012high 1 (2019) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Clariance, Sas by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clariance, Sas’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, Lumbar6decisions
  • NKBThoracolumbosacral Pedicle Screw System6decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2decisions
  • OLOOrthopedic Stereotaxic Instrument1decision

Also: ODP (1).

How long do its 510(k) reviews take?

Since 2016, its 19 510(k)s took a median of 65 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 14 of its 19 were faster than that.

Whose devices does it build on?

Its devices cite 44 predicates; 26 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 26 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.

  • K172083Idys™ ALIF SystemClariance, Sas · 20175cite it
  • K131178Idys Lif CagesClariance · 20135cite it
  • K153326Erisma-LP Spinal Fixation SystemClariance, Sas · 20162cite it
  • K120469Erisma-LPClariance · 20122cite it
  • K200920Idys ALIF ZP 3DTiClariance, Sas · 20202cite it
  • K192168Idys ALIF ZP 3DTiClariance, Sas · 20192cite it

What has FDA decided for it lately?

  • K243904Elegance® Anterior Cervical plateClariance · 20251 recall
  • K243670Idys® LIFClariance · 2024
  • K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
  • K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
  • K240715Idys® C ZP 3DTiClariance · 2024
  • K220182Aggeris™-CClariance · 2022
  • K212562Idys-C ZP 3DTiClariance, SA · 2021
  • K200919Idys ALIF 3DTiClariance · 2021

All 11 as Clariance, Sas →All 10 as Clariance →The one decision as Clariance, SA →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K243904Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL…Feb 20, 2026Class II
  • K153326Erisma- LP posterior fixation system with the below specifically affected products: 1.…Jul 1, 2019Class III