MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
FDA 510(k) K254087 · Synthes (USA) Products, LLC
510(k) numberK254087
Submission
- Device name
- MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- December 18, 2025
- Decision date
- June 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
|---|---|---|
| K212943 | SyntheCel Dura RepairGXQ · Traditional | 01/28/2022SE |
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| K210408 | DePuy Synthes Variable Angle Locking Patella Plating SystemHRS · Traditional | 04/08/2021SE |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemHRS · Traditional | 03/26/2021SE |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…HSB · Traditional | 09/23/2020SE |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalGXN · Traditional | 09/18/2020SE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY · Special | 09/10/2020SE |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating SystemHRS · Traditional | 09/09/2020SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | 09/03/2020SE |
| K191463 | DePuy Synthes Hammertoe Continuous Compression ImplantJDR · Traditional | 02/26/2020SE |
Questions and answers
When was MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System cleared by the FDA?
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System (K254087) received a 510(k) decision of Substantially Equivalent on June 11, 2026, 175 days after the submission was received.
What is the product code of K254087?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.