FDA.reportPublic FDA data

510(k) K251771

Device
Cambridge Partial Knee
Applicant
Signature Orthopaedics Pty, Ltd.
510(k) number
K251771
Product code
HSX
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-16
Date received
2025-06-10
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
N

Applicant Contact#

Contact
Declan Brazil
Address
7 Sirius Rd. Lane Cove West AU 2066 2066

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
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
K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.2021-09-16