Identifiers
- 510(k) Number
- K163379 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The KneeAlign 2 System is a diagnostic device classified as an orthopedic alignment assessment tool. It is designed to evaluate knee joint alignment and provide measurements for preoperative planning in orthopedic surgeries, particularly total knee arthroplasty.
This system is supplied as a reusable diagnostic tool and is intended for use in clinical settings such as orthopedic offices and hospitals. It is not sterile and requires proper calibration and maintenance as per manufacturer guidelines. The device holds FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD).
Frequently asked questions
What is the primary purpose of the KneeAlign 2 System in clinical settings?
The KneeAlign 2 System is designed specifically to assess knee joint alignment, providing precise measurements that aid in preoperative planning for orthopedic surgeries—particularly total knee arthroplasty. By evaluating alignment, it helps clinicians make informed decisions to improve surgical outcomes.
Is the KneeAlign 2 System intended for single-use or reusable applications in a clinical environment?
The KneeAlign 2 System is supplied as a reusable diagnostic tool, meaning it is meant for repeated use in clinical settings like orthopedic offices and hospitals. However, it is not sterile, so proper cleaning, calibration, and maintenance as outlined by the manufacturer are required before each use.
How does the KneeAlign 2 System differ from other orthopedic alignment assessment tools in terms of regulatory approval?
The KneeAlign 2 System holds FDA 510(k) clearance under the Traditional pathway, with a decision classification of *Substantially Equivalent* (SESE) and was reviewed by the Orthopedic Devices Panel (OR). It also complies with the Medical Device Directive (MDD), distinguishing it as a validated diagnostic tool for knee alignment assessment in regulated markets.
What type of clinical environments is the KneeAlign 2 System intended for, and what considerations should be made during storage?
The KneeAlign 2 System is intended for use in orthopedic offices and hospitals, where precise alignment assessments are critical. Since it is reusable and non-sterile, storage should follow manufacturer guidelines to prevent contamination and ensure proper calibration. It should be kept in a clean, controlled environment to maintain accuracy and functionality for repeated clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K163379 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthalign, Inc.
Sources (2)
- FDA 510(k) K163379 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026