Conformis Metal Backed Tibial Component (MBT)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063432 FDA 510(k)
- FDA Product Code
- HSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3520 FDA 510(k)
- Regulation Number
- 888.3520 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a metal backed tibial component used in orthopedic applications. It is a substantially equivalent device cleared through the traditional 510(k) pathway.
The device is manufactured by Conformis, Inc. and is identified by K-number K063432 and product code HSX. It received FDA 510(k) clearance on March 16, 2007.
Frequently asked questions
What is the Conformis Metal Backed Tibial Component (MBT) used for?
The Conformis Metal Backed Tibial Component (MBT) is used in orthopedic applications as a tibial component in knee replacement systems, providing structural support and articulation with the femoral component.
How is the Conformis Metal Backed Tibial Component (MBT) supplied or identified?
The device is identified by its model name, Conformis Metal Backed Tibial Component (MBT), K-number K063432, and product code HSX, and is manufactured by Conformis, Inc. at their facility in Foster City, California.
What regulatory pathway was used for the Conformis Metal Backed Tibial Component (MBT)?
The device received FDA 510(k) clearance through the traditional pathway, determined to be substantially equivalent to a predicate device, as indicated by its decision code SESE and clearance date of March 16, 2007.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063432 | Class II | Active |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K063432 24 fields · synced Sep 23, 2026