TITAN 3-D Wedge System
FDA 510(k)Class II (US FDA 510(k))
by Paragon 28
Identifiers
- 510(k) Number
- K162241 FDA 510(k)
- FDA Product Code
- PLF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TITAN 3-D Wedge System is an osteotomy wedge device designed for lateral column lengthening in foot and ankle surgery. It features an open geometry with a three-dimensional scaffold that allows for blood entry, bone through growth, and incorporation of biologics if used. The device provides a porous titanium alternative to allograft/autograft bone for Evans Calcaneal Osteotomy procedures.
The TITAN 3-D Wedge System is manufactured by Paragon 28 and is available in various sizes. It is a single-use device and requires appropriate storage conditions. The device has received FDA 510(k) clearance with K number K162241 and is classified under product code PLF for orthopedic use.
Frequently asked questions
What is the TITAN 3-D Wedge System used for?
The TITAN 3-D Wedge System is an osteotomy wedge device designed for lateral column lengthening in foot and ankle surgery. It serves as a porous titanium alternative to allograft/autograft bone for Evans Calcaneal Osteotomy procedures.
How is the TITAN 3-D Wedge System supplied and what are its storage requirements?
The TITAN 3-D Wedge System is manufactured by Paragon 28 and is available in various sizes. It is a single-use device that requires appropriate storage conditions to maintain its integrity and functionality.
What is the regulatory status of the TITAN 3-D Wedge System?
The TITAN 3-D Wedge System has received FDA 510(k) clearance with K number K162241 and is classified under product code PLF for orthopedic use. It was determined to be substantially equivalent to predicate devices.
What are the key features of the TITAN 3-D Wedge System?
The device features an open geometry with a three-dimensional scaffold that allows for blood entry, bone through growth, and incorporation of biologics if used. This porous titanium structure promotes bone integration while providing structural support.
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: TITAN 3-D™ Evans Lateral Column Lengthening Wedge - Paragon 28, PDF SURGICAL TECHNIQUE GUIDE - paragon28.com, TITAN 3-D Evans Lateral Column Lengthening Wedge
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162241 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA 510(k) K162241 24 fields · synced Sep 24, 2026