Trigon HA Stand-Alone Wedge Fixation System
FDA 510(k) K223226 · Nvision Biomedical Technologies, Inc.
510(k) numberK223226
Submission
- Device name
- Trigon HA Stand-Alone Wedge Fixation System
- Applicant
- Nvision Biomedical Technologies, Inc.
San Antonio, TX, US - Received
- October 18, 2022
- Decision date
- December 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLF – Bone Wedge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
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| K252254 | Osteotomy Wedge SystemPLF · Traditional | Sinaptic Surgical | 10/17/2025SE |
| K251791 | Auxano® Wedge Fixation SystemPLF · Traditional | Auxano Medical, LLC | 09/25/2025SE |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessoriesPLF · Abbreviated | Ames Medical Prosthetic Solutions, S.A.U. | 12/06/2024SE |
| K243231 | Trigon PEEK HA WedgesPLF · Special | Nvision Biomedical Technologies | 11/08/2024SE |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies | 01/26/2024SE |
| K231496 | TITAN 3-D Wedge SystemPLF · Traditional | Paragon 28, Inc. | 08/22/2023SE |
| K220197 | Trigon HA Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies, Inc. | 02/23/2022SE |
| K201314 | Restor3d Utility WedgePLF · Traditional | Restor3D, Inc. | 06/17/2021SE |
| K203445 | Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies, Inc. | 12/21/2020SE |
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| K253718 | enHAnce PEEK Bunion SystemHRS · Traditional | 04/01/2026SE |
| K260291 | Vortex5 Tailor's Bunion Correction SystemHRS · Traditional | 03/25/2026SE |
| K253423 | ToeJack MIS Bunion SystemHRS · Traditional | 11/18/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | 09/19/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | 06/11/2025SE |
| K250613 | SnapHammer Hammertoe Correction SystemHWC · Special | 04/02/2025SE |
| K242896 | Caliber Intramedullary Fixation SystemHWC · Traditional | 02/05/2025SE |
| K243231 | Trigon PEEK HA WedgesPLF · Special | 11/08/2024SE |
| K240250 | 3D Printed PEEK Interbody SystemMAX · Traditional | 09/17/2024SE |
| K231453 | SnapHammer Hammertoe Correction SystemHWC · Traditional | 02/16/2024SE |
Questions and answers
When was Trigon HA Stand-Alone Wedge Fixation System cleared by the FDA?
Trigon HA Stand-Alone Wedge Fixation System (K223226) received a 510(k) decision of Substantially Equivalent on December 1, 2022, 44 days after the submission was received.
What is the product code of K223226?
The FDA product code is PLF – Bone Wedge, a Class II (moderate risk) device regulated under 21 CFR 888.3030.