DeviceClearance

MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System— 510(k) K254087

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K254087 for MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System, Substantially Equivalent on 2026-06-11. Applicant: Synthes (USA) Products, LLC. Device class: 2.

Summary

Synthes (USA) Products' MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System is filed under KTT, multiple-component nail/blade/plate combination fixation appliances. The Bluetooth reference comes from the device name; the record doesn't list components.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Synthes filed from West Chester, Pennsylvania. Review took 175 calendar days (December 18, 2025 to June 11, 2026).

Clearance details

Applicant
Synthes (USA) Products, LLC
Product code
Product code KTT
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Chester, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.