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Fast-Fix Flex

by Smith & Nephew, Inc.

510(k) K203393

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203393 Date1 Feb 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GAT
Device class
Class II
Regulation
21 CFR Part 878.5000
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fast-Fix Flex is a meniscal repair system designed for all-zone all-inside meniscal repair. It enables treatment of meniscal tears that were previously not accessible through a quick and reproducible all-inside approach.

The device is supplied by Smith & Nephew, Inc. and has received FDA 510(k) clearance under K203393. It is intended for use in general and plastic surgery settings as indicated by the advisory committee classification.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Fast-Fix Flex used for?

    The Fast-Fix Flex is designed for all-zone all-inside meniscal repair, enabling treatment of meniscal tears that were previously not accessible through a quick and reproducible all-inside approach.

  • How is the Fast-Fix Flex supplied and by whom?

    The Fast-Fix Flex is supplied by Smith & Nephew, Inc., as indicated in the device data under manufacturer and applicant fields.

  • What regulatory pathway was used for the Fast-Fix Flex?

    The Fast-Fix Flex received FDA 510(k) clearance under K203393, as stated in the authorizations and specifications sections of the device data.

  • In what clinical settings is the Fast-Fix Flex intended for use?

    The device is intended for use in general and plastic surgery settings, as indicated by the advisory committee classification in the device data.