FDA Device Entity Profile: Howmedica Osteonics Corp.

Known Identifiers & Locations

FEI Numbers 3003070421

Owner Operator Numbers N/A

Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (2)

Submission #	Device Name	Decision Date	Decision Description	Action
K033476	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20	Substantially Equivalent	View Details
K033769	EIUS UNICOMPARTMENTAL KNEE SYSTEM	2004-02-13	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0023-2025	Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200 Reason: Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.	2024-09-04	Open, Classified	View Details

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