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Nexgen Porous HA/TCP Uncemented Femoral and Tibial Baseplate Components

by Zimmer, Inc.

510(k) K041100

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 · Special NumberK041100 Date29 Oct 2004ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1031-2018 FDA Class II initiated 29 Nov 2017
    • Terminated Z-1048-2018 FDA Class II initiated 29 Nov 2017
    • Terminated Z-1032-2018 FDA Class II initiated 29 Nov 2017

    The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

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  • Withdrawn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
MBH
Device Class
Class II
Regulation
21 CFR Part 888.3565
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.

This device is a porous-coated, hydroxyapatite/tricalcium phosphate (HA/TCP) femoral and tibial baseplate designed for uncemented fixation in total knee arthroplasty. It falls under the nomenclature for uncemented knee components, providing a biological interface for osseointegration without the use of bone cement.

The components are intended for use in orthopedic surgery settings and are supplied sterile for single-use. They are classified under FDA 510(k) clearance (K041100) as substantially equivalent to a predicate device, with no third-party labeling. Storage and handling must comply with sterile medical device protocols, and MRI safety considerations should be evaluated based on material composition.

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