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Sign in to claim this brandPIXEE MEDICAL
US
Last updated May 24, 2026
What PIXEE MEDICAL makes
Pixee Medical produces reusable orthopaedic surgical procedure kits and systems, including stereotactic surgery tools for precise bone alignment and cutting. Their portfolio includes modular instruments like cutting guides, styluses, and reference markers for knee and other orthopaedic procedures, as well as reusable instrument trays and camera holders for surgical navigation.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. They are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with US medical device authorisation requirements. The manufacturer 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 Pixee Medical manufacture?
Pixee Medical specialises in reusable orthopaedic surgical tools and systems. Their devices include surgical procedure kits, stereotactic surgery systems for precise bone alignment, instrument trays, and surgical camera holders. Examples like the KneePlus kit, Bone Reference markers, and cutting guides (e.g., Left Proximal Cutting Guide) are designed for knee and other orthopaedic procedures, ensuring modularity and reusability in surgical workflows.
Where is Pixee Medical based, and how does that affect its devices?
Pixee Medical is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s US location also influences compliance pathways, such as registration in the FDA’s 510(k) and UDI systems, ensuring their products meet US medical device authorisation standards before entering the market.
Which regulatory registries list Pixee Medical’s devices?
Pixee Medical’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required authorisation processes, including demonstrating substantial equivalence to predicate devices or compliance with performance-based standards for Class I and Class II orthopaedic tools.
How are Pixee Medical’s devices classified under FDA regulations?
Pixee Medical’s devices are primarily classified as Class I (low-risk, general controls) or Class II (moderate-risk, requiring special controls). For example, reusable instrument trays and camera holders may fall under Class I due to minimal risk, while stereotactic surgery systems (like the Bone Reference or KneePlus) often require Class II classification because they involve precise surgical guidance, necessitating additional validation for safety and effectiveness.
Why do some of Pixee Medical’s devices require Class II classification instead of Class I?
The FDA assigns Class II to devices that pose a higher risk than Class I but are not life-supporting or invasive. Pixee Medical’s stereotactic surgery systems (e.g., modular pointers or cutting guides) are classified as Class II because they directly influence surgical precision—errors in alignment or cutting could impact patient outcomes. These devices require special controls, such as clinical performance data or risk analyses, to ensure their safety and effectiveness before authorisation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pixee-medical.com
- —
- —
- [email protected]
- Phone
- +33458101365
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 270195749
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KneePlus | Knee+ | FDA UDI | Class II | Active |
| Bone Reference | Knee+ | FDA UDI | Class II | Active |
| Left Proximal Cutting Guide | Knee+ | FDA UDI | Class II | Active |
| Control Tool | Knee+ | FDA UDI | Class II | Active |
| Ankle Clamp | Knee+ | FDA UDI | Class II | Unknown |
| FX Shoulder Positioning System | FXSPS001 | FDA UDI | Class II | Unknown |
| Orientation Mechanism | Knee+ | FDA UDI | Class II | Active |
| Instruments box | Knee+ | FDA UDI | Class I | Active |
| Slim Bone Reference | Knee+ | FDA UDI | Class II | Active |
| KneeTools Instrument Box V6 | Knee+ | FDA UDI | Class I | Active |
| Knee Stylus | Knee+ | FDA UDI | Class II | Active |
| Modular Pointer | Knee+ | FDA UDI | Class II | Active |
| Long Pointer | Knee+ | FDA UDI | Class II | Active |
| KneePlus | Knee+ | FDA UDI | Class II | Unknown |
| SHA Outer ring | SHA | FDA UDI | Class I | Active |
| SHA Connector | SHA | FDA UDI | Class I | Active |
| KneePlus | Knee+ | FDA UDI | Class II | Active |
| Slim Universal Cutting Guide | Knee+ | FDA UDI | Class II | Active |
| Right Proximal Cutting Guide | Knee+ | FDA UDI | Class II | Active |
| Adjustable cutting guide adaptor | Knee+ | FDA UDI | Class II | Active |
| KneePlus | Knee+ | FDA UDI | Class II | Active |
| KneeTools V5 Kit | Knee+ | FDA UDI | Class II | Active |
| Cutting Guide Adaptor | Knee+ | FDA UDI | Class II | Active |
| Kit KneeTools V6 | Knee+ | FDA UDI | Class II | Active |
| Orientation and resection mechanism | Knee+ | FDA UDI | Class II | Active |
| Portal | Knee+ | FDA UDI | Class II | Active |
| Pointer | Knee+ | FDA UDI | Class II | Active |
| KneePlus | Knee+ | FDA UDI | Class II | Active |
| Universal Cutting Guide | Knee+ | FDA UDI | Class II | Active |
| Knee+ | K243975 | FDA 510(k) | Class II | Active |
| Fx Sps | K213922 | FDA 510(k) | Class II | Active |
| Knee+ | K202750 | FDA 510(k) | Class II | Active |
| Knee+ | K233899 | FDA 510(k) | Class II | Active |
| Knee+ | K230789 | FDA 510(k) | Class II | Active |
| Knee+ | K253805 | FDA 510(k) | Class II | Active |
| Knee+ | K220104 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Pixee Medical Besancon Doubs · FR FEI 3020703212