FDA applicant

Pivot Medical

Sunnyvale, CA5 decisions2011–20154 recalls

FDA records 5 decisions for Pivot Medical (Sunnyvale, CA) from 2011 to 2015: 5 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 8 predicates, 3 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Pivot Medical, Inc.”.

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 Pivot Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011high 3 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2025

2011high 2 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Pivot Medical by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pivot Medical’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

Other applicant names beginning “Pivot”

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

Pivot Assist, LLC 1

Pivot Medical

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 “Pivot”