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510(k) K211471

Device
Balanced Knee System Uni
Applicant
Ortho Development Corporation
510(k) number
K211471
Product code
HSX  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-16
Date received
2021-05-11
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
Divya Palan
Address
12187 S. Business Park Dr. Draper UT US 84020 84020

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
K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.2021-11-16
K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.2021-10-12
K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.2021-09-16

Legacy Summary#

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FDA Review#

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