# Ortho-Design (Pty), Ltd.

- Location (FDA's records): Pretoria, ZA
- FDA decisions: 2 (2021–2024): 2 510(k) clearances
- Product codes: MBI (2)
- Predicates its devices cite: 16 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 7 (https://510kreport.com/company/arthrex)
- Parcus Medical, LLC: 4 (https://510kreport.com/company/parcus-medical)
- Depuy Mitek, A Johnson & Johnson Company: 3 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi (2021), cited by 1

## Recent decisions
- K242296: VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (Aug 29, 2024)
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi (Dec 6, 2021)

Source page: https://510kreport.com/company/ortho-design