b-ONE MOBIO Total Knee System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213673 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The b-ONE MOBIO Total Knee System is a total knee prosthesis designed for arthroplasty, replacing damaged or diseased knee joints. It is classified under the orthopedic device nomenclature for knee replacements, intended to restore function and alleviate pain in patients with degenerative joint conditions, including osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. The system is engineered to address joint deformities and restore anatomical alignment, improving mobility and quality of life for affected individuals.
This system is supplied as a sterile, single-use orthopedic implant, intended for use in hospital operating rooms under aseptic conditions. It is MRI-safe and available in standardized sizes to accommodate varying patient anatomies. The device holds FDA 510(k) clearance (K213673) under the Traditional 510(k) Review Pathway, with a Substantially Equivalent determination by the Orthopedic Devices Panel. Storage and handling must comply with manufacturer guidelines to maintain sterility and integrity prior to surgical 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. Sources consulted: THINK Surgical Announces First Use of b-ONE Ortho Corporation's MOBIO, b-ONE MOBIO Total Knee System (K213673) — FDA 510(k) | Innolitics, THINK Surgical Announces First Use of b-ONE Ortho Corporation's MOBIO ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213673 | Class II | Active |
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Manufacturer
- Manufacturer
- B-One Ortho, Corp.
Sources (1)
- FDA 510(k) K213673 24 fields · synced Sep 19, 2026