510(k) Report

FDA applicant

Medicrea International SA

Neyron, FR44 decisions2011–202611 recalls

FDA records 44 decisions for Medicrea International SA (Neyron, FR) from 2011 to 2026: 44 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and OWI (Bone Fixation Cerclage, Sublaminar). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 119 predicates, 41 of them its own earlier devices. 11 recalls are linked to its devices.

FDA’s records also spell it “Medicrea International”, “Medicrea International, Inc.”, “Medicrea International S.A.S”.

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 Medicrea International SA’s devices, and how often a recall has named them.

FDA decisions per year

5in 2022

2011: 22012: 22013: 52014: 22015: 52016: 82017: 42018: 42019: 42020: 12021: 12022: 52026 (partial year): 1
2011high 8 (2016) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2024

2019: 52020: 22023: 32024: 1
2011high 5 (2019) · low 0 (2011)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System9decisions
  • OWIBone Fixation Cerclage, Sublaminar6decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar6decisions
  • NKGPosterior Cervical Screw System5decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis3decisions

Also: MNI (3), KWQ (2), MNH (2), OVD (1), KWP (1), PHQ (1).

How long do its 510(k) reviews take?

Since 2016, its 26 510(k)s took a median of 120 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 11 of its 26 were faster than that.

Whose devices does it build on?

Its devices cite 119 predicates; 41 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 69 times; 41 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.

  • K140738Pass LP Spinal SystemMedicrea International · 20149cite it
  • K123138Pass LP Spinal SystemMedicrea International · 20136cite it
  • K163595IMPIX 3D Print CagesMedicrea International SA · 20175cite it
  • K150918PASS OCT Spinal SystemMedicrea International SA · 20154cite it
  • K141398Pass LP Spinal SystemMedicrea International SA · 20154cite it
  • K112736Pass LP SpinalMedicrea International · 20124cite it

What has FDA decided for it lately?

  • K261374LigaPASS™ SystemMedicrea International S.A.S · 2026
  • K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022
  • K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International · 2022
  • K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International · 2022
  • K212005UNiD Spine AnalyzerMedicrea International, Inc. · 20221 recall
  • K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
  • K210470C-CURVE Interbody Fusion DeviceMedicrea International SA · 2021
  • K200316UNiD IB3D ALIFMedicrea International SA · 2020

All 25 as Medicrea International SA →All 17 as Medicrea International →The one decision as Medicrea International, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K212005UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code…Dec 3, 2024Class II
  • K110497PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e)…Jul 12, 2023Class II
  • K163595IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d)…Jul 12, 2023Class II
  • K141187IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbarJul 12, 2023Class II
  • K190376Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590…Jan 28, 2020Class II
  • K190376Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540…Jan 28, 2020Class II

Other applicant names beginning “Medicrea”

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

Medicrea Technologies 14Medicrea 4Medicrea International S.A.S. (Medtronic) 4