FDA applicant

Ortho-Design (Pty), Ltd.

Pretoria, ZA2 decisions2021–20240 recalls

FDA records 2 decisions for Ortho-Design (Pty), Ltd. (Pretoria, ZA) from 2021 to 2024: 2 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 16 predicates, 1 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-Design (Pty), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ortho-Design (Pty), Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ortho-Design (Pty), Ltd.’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 “Ortho-Design”

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-Design (Pty), Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ortho-Design”