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Nexflex Total Knee System

by Nexmed, Inc.

510(k) K991882

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 NumberK991882 Date8 Dec 1999ClearedStatusActive

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  • Withdrawn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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Nexflex Total Knee System is a total knee replacement device indicated for painful, disabling joint disease resulting from rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis. It is also indicated for failed osteotomies, unicompartmental replacement, or total knee replacement, and post-traumatic loss of knee joint configuration and function.

The device received FDA 510(k) clearance (K991882) on December 8, 1999, following a traditional review process. It is manufactured by Nexmed, Inc. and is authorized for distribution in the United States.

Other devices from Nexmed, Inc.

Questions

AI-generated answers, 19 Sep 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 Nexflex Total Knee System intended for?

    The Nexflex Total Knee System is indicated for painful, disabling joint disease resulting from rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis. It is also indicated for failed osteotomies, unicompartmental replacement, or total knee replacement, and post-traumatic loss of knee joint configuration and function.

  • How was the Nexflex Total Knee System cleared for marketing in the United States?

    The device received FDA 510(k) clearance (K991882) on December 8, 1999, following a traditional review process, and was found substantially equivalent to a predicate device.

  • Who manufactures the Nexflex Total Knee System and where is it authorized for distribution?

    The Nexflex Total Knee System is manufactured by Nexmed, Inc. and is authorized for distribution in the United States.

  • What regulatory pathway was used for the Nexflex Total Knee System's clearance?

    The device underwent a traditional 510(k) review process, which is a premarket notification pathway used to demonstrate substantial equivalence to a legally marketed device.

  • What advisory committee was involved in the review of the Nexflex Total Knee System?

    The Orthopedic (OR) advisory committee was involved in the review of the Nexflex Total Knee System during its 510(k) submission process.