510(k) Report

FDA applicant

Resorbable Orthopedic Products, LLC

Addison, TX1 decision2016–20160 recalls

FDA records 1 decision for Resorbable Orthopedic Products, LLC (Addison, TX) in 2016: 1 510(k) clearance. All are in product code MTJ (Wax, Bone). Its devices cite 1 predicate, 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

How often FDA has decided Resorbable Orthopedic Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Resorbable Orthopedic Products, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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