510(k) Report

FDA applicant

Interpore Cross Intl.

Irvine, CA39 decisions1998–20052 recalls

FDA records 39 decisions for Interpore Cross Intl. (Irvine, CA) from 1998 to 2005: 39 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 16 predicates, 7 of them its own earlier devices. 2 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 Interpore Cross Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Interpore Cross Intl. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Interpore Cross Intl. 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?

  • MQPSpinal Vertebral Body Replacement Device10decisions
  • KWPAppliance, Fixation, Spinal Interlaminal7decisions
  • MNIOrthosis, Spinal Pedicle Fixation6decisions
  • MQVFiller, Bone Void, Calcium Compound5decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • CACApparatus, Autotransfusion2decisions

Also: JDK (2), MNH (1), FMF (1), FJI (1), FMG (1).

Whose devices does it build on?

Its devices cite 16 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 144 times; 7 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.

  • K990131Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 199918cite it
  • K033961Altius Oct SystemInterpore Cross Intl. · 200413cite it
  • K011437Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl. · 200112cite it
  • K000236Synergy VLS Cap Nut Models 2206, 6102Interpore Cross Intl. · 200012cite it
  • K041449Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatInterpore Cross Intl. · 200411cite it
  • K040928Expandable Peek VBR ImplantInterpore Cross Intl. · 200410cite it

What has FDA decided for it lately?

  • K050861Peek CasInterpore Cross Intl. · 2005
  • K031399Intergro DBMInterpore Cross Intl. · 20051 recall
  • K041407Titanium Mesh ImplantInterpore Cross Intl. · 2004
  • K043229Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004
  • K040928Expandable Peek VBR ImplantInterpore Cross Intl. · 2004
  • K041794C-Tek C-Thru Anterior Cervical Plate SystemInterpore Cross Intl. · 2004
  • K041449Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatInterpore Cross Intl. · 2004

All 39 as Interpore Cross Intl. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K031399InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002…Oct 15, 2007
  • K040168Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers)Jan 14, 2005

Other applicant names beginning “Interpore”

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

Interpore Intl. 26