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510(k) K200151

Device
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter
Applicant
Zimmer, Inc.
510(k) number
K200151
Product code
HSX  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-17
Date received
2020-01-22
Regulation
888.3520
Classification name
Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pankti Shah
Address
1800 W. Center St. Warsaw IN US 46580 46580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HSX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2026-04-02
K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.2025-12-16
K251834Persona Partial KneeZimmer Biomet2025-08-15
K251618MOTO Partial Knee System ExtensionMedacta International S.A.2025-07-24
K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.2025-07-01
K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.2024-12-06
K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.2024-10-30
K242746OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics2024-10-07
K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.2024-04-04
K221292Uni Knee Resurfacing SystemOverture Resurfacing, Inc.2023-03-10
K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.2022-06-16
K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.2022-06-02
K211471Balanced Knee System UniOrtho Development Corporation2021-12-16
K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.2021-11-16
K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.2021-10-12

Legacy Summary#

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FDA Review#

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