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Sign in to claim this brandORTHO-DESIGN (PTY) LTD
US
Last updated May 24, 2026
What ORTHO-DESIGN (PTY) LTD makes
Ortho-Design (Pty) Ltd manufactures non-bioabsorbable tendon and ligament bone anchors, including threaded variants in materials such as PEEK and titanium, as well as composite titanium-PEEK anchors. Their portfolio also includes reusable orthopaedic tools like fluted surgical drill bits, screw-extraction reamers, and orthopaedic screw starters/notchers, including specific models like the DueLock and VersaTap systems.
These devices are regulated under FDA classifications, with most falling into Class I and Class II categories, and are listed under the 510(k) and UDI programs. The company operates from the US, adhering to applicable regulatory requirements for surgical and orthopaedic instrumentation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Ortho-Design (Pty) Ltd manufacture?
Ortho-Design (Pty) Ltd specializes in orthopaedic devices, primarily focusing on non-bioabsorbable tendon and ligament bone anchors. These anchors come in various materials, including PEEK, titanium, and composite titanium-PEEK, such as the Anchor Threaded PEEK, Anchor Threaded Titanium, and Anchor Threaded Titanium-PEEK. Additionally, the company produces reusable orthopaedic surgical tools like fluted drill bits, screw-extraction reamers, and screw starter/notcher systems, including models like the DueLock and VersaTap.
Where is Ortho-Design (Pty) Ltd based, and how does this affect its regulatory compliance?
Ortho-Design (Pty) Ltd is based in the US, which means its devices are subject to FDA regulations. The company’s products are designed to comply with US regulatory standards, including classification under the FDA’s Class I and Class II categories, and registration under the 510(k) premarket notification process and the Unique Device Identifier (UDI) system.
Which regulatory registries or programs list Ortho-Design’s devices?
Ortho-Design’s devices are listed under the FDA’s 510(k) premarket notification program, which ensures they meet regulatory standards before entering the market. Additionally, they are registered under the FDA’s UDI system, which assigns unique identifiers to medical devices to improve tracking and transparency in the healthcare supply chain.
How are Ortho-Design’s devices classified under FDA regulations?
Ortho-Design’s devices are primarily classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may be exempt from some premarket submissions, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as bone anchors or reusable surgical tools.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ortho-design.co.za
- —
- —
- [email protected]
- Phone
- +27128075172
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 557386523
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anchor Threaded PEEK | ATP-5.5x15 2S N | FDA UDI | Class II | Active |
| Anchor Threaded Titanium | ATT-6x17 2S N | FDA UDI | Class II | Active |
| VersaPEEK | APP001 | FDA UDI | Class II | Active |
| Anchor Threaded Titanium | ATT-2x6 2S ND | FDA UDI | Class II | Active |
| DueLock | ADP011 | FDA UDI | Class II | Active |
| Anchor Impact PEEK | ABP-2.9x10 S N | FDA UDI | Class II | Active |
| DueLock 2.9mm Drill | ADP013 | FDA UDI | Class I | Active |
| Anchor Threaded Titanium-PEEK | ATX-6.5x17 ST | FDA UDI | Class II | Active |
| VersaTap/Lat Removal Tool | ADP003-1 | FDA UDI | Class I | Active |
| Anchor Threaded Titanium-PEEK | ATX-6.5x17 2T | FDA UDI | Class II | Active |
| VersaTap Tip Removal | ADP004-1 | FDA UDI | Class I | Active |
| VersaPEEK | APP002-N | FDA UDI | Class II | Active |
| VersaTi 6mm Drill | ATP001-01 | FDA UDI | Class I | Active |
| VersaPEEK | APP001-N | FDA UDI | Class II | Active |
| VersaTi | ATP002 | FDA UDI | Class II | Active |
| VersaTap | ADP001-T2 | FDA UDI | Class II | Active |
| VersaTi 4mm Drill | ATP002-01 | FDA UDI | Class I | Active |
| VersaTi 3mm Drill | ATP004-01 | FDA UDI | Class I | Active |
| VersaPEEK Tap | APP001-1 | FDA UDI | Class I | Active |
| VersaTap | ADP005 | FDA UDI | Class II | Active |
| Anchor Threaded Titanium-PEEK | ATX-6.5x17 2S | FDA UDI | Class II | Active |
| VersaTi | ATP004 | FDA UDI | Class II | Active |
| DoubleTap | ADP009-2 | FDA UDI | Class I | Active |
| MiniTi | ATP003 | FDA UDI | Class II | Active |
| Anchor Threaded Titanium | ATT-4x13 2S N | FDA UDI | Class II | Active |
| VersaTi | ATP001 | FDA UDI | Class II | Active |
| VersaPEEK | APP002 | FDA UDI | Class II | Active |
| VersaTap | ADP001-T1 | FDA UDI | Class II | Active |
| VersaTap Tip Recovery | ADP004-2 | FDA UDI | Class I | Active |
| VersaTap | ADP001 | FDA UDI | Class II | Active |
| Anchor Threaded Titanium-PEEK | ATX-6.5x17 2S N | FDA UDI | Class II | Active |
| DoubleTap | ADP009-1 | FDA UDI | Class I | Active |
| Anchor Threaded Titanium | ATT-3x11 2S N | FDA UDI | Class II | Active |
| VersaPEEK Tapping Tool | APP001-2 | FDA UDI | Class I | Active |
| VersaTap /VersaLat Recovery | ADP003-2 | FDA UDI | Class I | Active |
| VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) | K242296 | FDA 510(k) | Class II | Active |
| VersaTap, VersaLat, DueLock, VersaTi, MiniTi | K212381 | FDA 510(k) | Class II | Active |
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