K231496 is an FDA 510(k) clearance for the TITAN 3-D Wedge System. This device is classified as a Bone Wedge (Class II - Special Controls, product code PLF).
Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on August 22, 2023, 90 days after receiving the submission on May 24, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia..
| 510(k) Number | K231496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2023 |
| Decision Date | August 22, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLF — Bone Wedge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia. |