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Sign in to claim this brandANATOMICS PTY LTD
US
Last updated May 30, 2026
What ANATOMICS PTY LTD makes
Anatomics Pty Ltd manufactures polyethylene-based craniofacial tissue reconstructive materials, such as StarPore, designed for soft tissue reconstruction in surgical procedures. They also produce custom-made anatomical models of organs and bones, as well as single-use surgical implant templates tailored for precise preoperative planning. The company’s StarPore product appears across multiple entries, indicating its use in various reconstructive applications.
The company’s devices are regulated under FDA classifications, including Class I and Class II, with several authorised via the 510(k) pathway and the Unique Device Identification (UDI) system. These products are listed under U.S. regulatory frameworks, reflecting compliance with FDA requirements for medical devices. Anatomics Pty Ltd is based in the United States.
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 Anatomics Pty Ltd manufacture?
Anatomics Pty Ltd specialises in polyethylene-based craniofacial tissue reconstructive materials, such as their StarPore product, which are used for soft tissue reconstruction in surgical procedures. They also create custom-made anatomical models of organs and bones, as well as single-use surgical implant templates designed for precise preoperative planning. These devices cater to reconstructive surgery and surgical planning needs.
Where is Anatomics Pty Ltd based?
Anatomics Pty Ltd is headquartered in the United States. The company’s location aligns with its regulatory focus on FDA-compliant medical devices, ensuring its products meet U.S. standards for safety and performance.
Which regulatory registries or databases list Anatomics Pty Ltd’s devices?
Anatomics Pty Ltd’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identification (UDI) system. These registries reflect the company’s compliance with U.S. medical device regulations, including premarket notifications and device tracking requirements.
How are Anatomics Pty Ltd’s devices classified under FDA regulations?
Anatomics Pty Ltd’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on the device’s intended use and potential risk to patients.
Why does the StarPore product appear repeatedly in Anatomics Pty Ltd’s device listings?
The repeated listing of StarPore suggests it is a versatile polyethylene-based reconstructive material used across multiple craniofacial and soft tissue reconstruction applications. Its broad use cases—such as in various surgical procedures—likely contributes to its frequent appearance in regulatory submissions and databases, indicating its role as a foundational product in the company’s portfolio.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- anatomics.com
- —
- —
- [email protected]
- Phone
- +61395298088
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 755739307
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| StarPore | CI-STARPORE-M | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-M2 | FDA UDI | Class II | Active |
| Surgical Template | TP-BRT | FDA UDI | Class I | Active |
| StarPore | CI-STARPORE-OT | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-O | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-XL | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-S | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-L | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-S2 | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-XL2 | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-L2 | FDA UDI | Class II | Active |
| StarPore | CI-STARPORE-SAMPLE | FDA UDI | Class II | Active |
| Surgical BioModel | BM-IMPLANT | FDA UDI | Class I | Active |
| StarPore | K200532 | FDA 510(k) | Class II | Active |
| PoreStar Patient Specific Implant | K171037 | FDA 510(k) | Class II | Active |
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