510(k) Report

FDA applicant

Pacific Materials and Interfaces

San Diego, CA3 decisions1997–19990 recalls

FDA records 3 decisions for Pacific Materials and Interfaces (San Diego, CA) from 1997 to 1999: 3 510(k) clearances. Most are in product codes JEY (Plate, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 14 predicates, 0 of them its own earlier devices. No 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 Pacific Materials and Interfaces’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pacific Materials and Interfaces since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pacific Materials and Interfaces’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JEYPlate, Bone1decision
  • HRSPlate, Fixation, Bone1decision
  • JDQCerclage, Fixation1decision

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 19985cite it
  • K983360Macropore Protective SheetPacific Materials and Interfaces · 19991cites it
  • K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 19971cites it

What has FDA decided for it lately?

  • K983360Macropore Protective SheetPacific Materials and Interfaces · 1999
  • K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998
  • K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997

All 3 as Pacific Materials and Interfaces →