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FDA 510(k)

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

K-Number: K211313 · 2021-05-25

ApplicantSynthes (USA) Products, LLC
Decision Date2021-05-25
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2021-05-25 under approval number K211313. 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 Multi-Axial Correction System (aka MAXFRAME)?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is a medical device that received FDA 510(k) clearance on 2021-05-25. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K211313.

When was MAXFRAME Multi-Axial Correction System (aka MAXFRAME) approved by the FDA?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) received FDA 510(k) clearance on 2021-05-25, under approval number K211313.

What company makes MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

The FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is KTT.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

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Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

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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