510(k) Report

FDA applicant

Altus Partners, LLC

West Chester, PA18 decisions2013–20250 recalls

FDA records 18 decisions for Altus Partners, LLC (West Chester, PA) from 2013 to 2025: 18 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 53 predicates, 17 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Altus Partners”.

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 Altus Partners, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013: 12015: 12017: 62018: 22019: 22020: 12021: 22022: 22025: 1
2013high 6 (2017) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Altus Partners, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Altus”

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