FDA applicant

Pontis Orthopaedics, LLC

San Francisco, CA2 decisions2014–20140 recalls

FDA records 2 decisions for Pontis Orthopaedics, LLC (San Francisco, CA) in 2014: 2 510(k) clearances. Most are in product codes GAQ (Suture, Nonabsorbable, Steel, Monofilament And…) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 7 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, general and plastic surgery panel, where it files most

How often FDA has decided Pontis Orthopaedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Pontis Orthopaedics, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pontis Orthopaedics, LLC’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 “Pontis”

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

Pontis Orthopaeeics, LLC 1

Pontis Orthopaedics, LLC

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?

Other applicant names beginning “Pontis”