510(k) Report

FDA applicant

Medicrea

Round Rock, TX4 decisions2003–20101 recall

FDA records 4 decisions for Medicrea (Round Rock, TX) from 2003 to 2010: 4 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 11 predicates, 1 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 Medicrea’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MQVFiller, Bone Void, Calcium Compound1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Whose devices does it build on?

Its devices cite 11 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K062136Pass 2 Spinal SystemMedicrea · 20063cite it
  • K032094Passmed Spinal SystemMedicrea · 20033cite it

What has FDA decided for it lately?

  • K100484Impix Manta Cervical Interbody DeviceMedicrea · 20101 recall
  • K062136Pass 2 Spinal SystemMedicrea · 2006
  • K050490Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea · 2005
  • K032094Passmed Spinal SystemMedicrea · 2003

All 4 as Medicrea →

What has been recalled?

1 recall linked to its devices; the latest:

  • K100484IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e)…Jul 12, 2023Class II

Other applicant names beginning “Medicrea”

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

Medicrea International SA 44Medicrea Technologies 14Medicrea International S.A.S. (Medtronic) 4