FDA applicant

Ortho-Pro, LLC

Round Rock, TX4 decisions2003–20110 recalls

FDA records 4 decisions for Ortho-Pro, LLC (Round Rock, TX) from 2003 to 2011: 4 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and KWH (Prosthesis, Toe, Constrained, Polymer). Its devices cite 6 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, orthopedic panel, where it files most

How often FDA has decided Ortho-Pro, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ortho-Pro, LLC’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 “Ortho-Pro”

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

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Diagnostics, Inc. 24 Ortho Tec, LLC 22 Ortho Pharmaceutical Corp. 9 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Instruments 6 Ortho Kinematics, Inc. 6

Ortho-Pro, 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 “Ortho-Pro”