FDA applicant

Stryker Biotech

Hopkinton, MA1 decision2004–20041 recall

FDA records 1 decision for Stryker Biotech (Hopkinton, MA) in 2004: 1 510(k) clearance. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 4 predicates, 0 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 Stryker Biotech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stryker Biotech since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stryker Biotech’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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Other applicant names beginning “Stryker”

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

Stryker Corp. 354 Stryker Endoscopy 103 Stryker Instruments 77 Stryker Spine 76 Stryker Leibinger GmbH & Co KG 36 Stryker Neurovascular 36 Stryker Sustainability Solutions 34 Stryker Trauma AG 32 Stryker Orthopaedics 24 Stryker Medical 14 Stryker Instruments, Instruments Div. 6 Stryker Corporate 6

Stryker Biotech

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Stryker”