510(k) Report

FDA applicant

Medicrea Technologies

Round Rock, TX14 decisions2007–20113 recalls

FDA records 14 decisions for Medicrea Technologies (Round Rock, TX) from 2007 to 2011: 14 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 21 predicates, 5 of them its own earlier devices. 3 recalls are 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 Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 52008: 42009: 12010: 32011: 1
2007high 5 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

3in 2023

2023: 3
2007high 3 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medicrea Technologies 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?

  • MNIOrthosis, Spinal Pedicle Fixation6decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation2decisions
  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Whose devices does it build on?

Its devices cite 21 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 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.

  • K072226Impix SpacerMedicrea Technologies · 200711cite it
  • K080099Pass Spinal SystemMedicrea Technologies · 20085cite it
  • K083810Pass LP Spinal SystemMedicrea Technologies · 20093cite it
  • K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 20103cite it
  • K100297Pass LP Spinal SystemMedicrea Technologies · 20103cite it
  • K062181C-Jaws Cervical Compressive Mini FrameMedicrea Technologies · 20073cite it

What has FDA decided for it lately?

  • K102406Pass Anterior Spinal SystemMedicrea Technologies · 2011
  • K100544Impix Lumbar Interbody DeviceMedicrea Technologies · 20101 recall
  • K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 20102 recalls
  • K100297Pass LP Spinal SystemMedicrea Technologies · 2010
  • K083810Pass LP Spinal SystemMedicrea Technologies · 2009
  • K083308Pass LP Spinal SystemMedicrea Technologies · 2008
  • K082069Pass 2 Spinal SystemMedicrea Technologies · 2008
  • K082577Pass LP Spinal SystemMedicrea Technologies · 2008

All 14 as Medicrea Technologies →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K083798IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e)…Jul 12, 2023Class II
  • K083798IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412…Jul 12, 2023Class II
  • K100544IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, 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 4Medicrea International S.A.S. (Medtronic) 4