510(k) Report

FDA applicant

Howmedica Osteonics Corp. Dba Stryker Orthopeadics

Mahwah, NJ1 decision2011–20110 recalls

FDA records 1 decision for Howmedica Osteonics Corp. Dba Stryker Orthopeadics (Mahwah, NJ) in 2011: 1 510(k) clearance. All are in product code GWO (Plate, Cranioplasty, Preformed, Alterable). Its devices cite 2 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, neurology panel, where it files most

How often FDA has decided Howmedica Osteonics Corp. Dba Stryker Orthopeadics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Howmedica Osteonics Corp. Dba Stryker Orthopeadics by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Howmedica Osteonics Corp. Dba Stryker…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GWOPlate, Cranioplasty, Preformed, Alterable1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 20112cite it

What has FDA decided for it lately?

  • K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011

The one decision as Howmedica Osteonics Corp. Dba Stryker Orthopeadics →

Other applicant names beginning “Howmedica”

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

Howmedica Corp. 412Howmedica Osteonics Corp. 303Howmedica Osteonics Corp., Dba Stryker Orthopaedics 34Howmedica Leibinger, Inc. 11Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics 11Howmedica, Pfizer Medical Technology Group 1