Skip to content

Natural-Knee® Durasul® 6276-01-613

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

10 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024255944 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

10 recalls · FDA

    • Terminated Z-2092-2023 FDA Class II initiated 19 May 2023

    Device outer packaging was incorrectly labeled.

    • Terminated Z-0321-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

  • 8 recalls, same reason

    • Terminated Z-0854-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0848-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0849-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0853-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0855-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0850-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0852-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0851-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011

    The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene, Durasul, patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Natural-Knee® Durasul®
Generic Name
Tibial insert
Model / Ref / Catalog
6276-01-613
Primary DI / UDI-DI
00889024255944
510(k) Number
FDA Product Code
JWH
GMDN Term
Tibial insert
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution
Size
Height — 13 Millimeter

Related devices

Category: Tibial insert

Cleared under the same submission (K002335)

Show all (12)

Cleared under the same submission (K173057)

Show all (12)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No