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FDA 510(k)

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

K-Number: K254087 · 2026-06-11

ApplicantSynthes (USA) Products, LLC
Decision Date2026-06-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K254087. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System?

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K254087.

When did MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System receive FDA 510(k) clearance?

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System received FDA 510(k) clearance on 2026-06-11, under 510(k) number K254087.

Who is the listed applicant for MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System?

The FDA product code for MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System is KTT.

Other records listing Synthes (USA) Products, LLC as applicant

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Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbHK252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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